CFAI
C.F.A.I.
Government Data Intelligence Services

Biomet, Inc.

Company IN
Found in 4 federal databases · 221 total records
co_sos 1 records
CO Business: BIOMET, INC. 1998-02-17
FPC | Status: Good Standing | Warsaw, IN
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fda 216 records
FDA Device Recall: Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 2025-10-01
Class II — The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
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FDA Recall: Biomet, Inc. — Class II 20240501
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. | Product: Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082...
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FDA Device Recall: Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 2024-05-01
Class II — Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
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FDA Recall: Biomet, Inc. — Class II 20231129
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in exte | Product: Compress Device Short Anchor Plug, 26 ...
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FDA Recall: Biomet, Inc. — Class II 20231129
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in exte | Product: Compress Device Short Anchor Plug, 24 ...
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FDA Recall: Biomet, Inc. — Class II 20231129
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in exte | Product: Compress Device Short Anchor Plug, 14 ...
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FDA Recall: Biomet, Inc. — Class II 20231129
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in exte | Product: Compress Device Short Anchor Plug, 28 ...
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FDA Recall: Biomet, Inc. — Class II 20230329
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. | Product: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Mode...
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FDA Device Recall: Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccess 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccess 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccess 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccess 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuc 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuc 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccess 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuc 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuc 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful 2023-11-29
Class II — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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FDA Device Recall: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Numbe 2023-03-29
Class II — The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
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FDA Device Recall: OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For us 2023-02-08
Class II — Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
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FDA Device Recall: (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee j 2023-02-08
Class II — Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
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FDA Device Recall: Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace 2023-02-01
Class II — Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the cart...
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FDA Device Recall: BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. 2022-03-30
Class II — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical interv...
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FDA Device Recall: BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item 2022-03-30
Class II — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical interv...
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FDA Device Recall: BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2 2022-03-30
Class II — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical interv...
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FDA Device Recall: BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item 2022-03-30
Class II — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical interv...
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FDA Device Recall: Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma 2022-03-02
Class II — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The...
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FDA Device Recall: Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A 2022-03-02
Class II — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The...
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FDA Device Recall: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Lon 2022-03-02
Class II — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The...
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FDA Device Recall: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Lon 2022-03-02
Class II — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The...
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FDA Device Recall: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Lon 2022-03-02
Class II — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The...
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FDA Recall: Biomet, Inc. — Class II 20210818
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical int | Product: Arcos Modular Revision Hip System Stan...
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FDA Recall: Biomet, Inc. — Class II 20210818
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical int | Product: Arcos Modular Revision Hip System Stan...
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FDA Device Recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item N 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Ite 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM I 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM I 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM I 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Ite 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM I 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM I 2021-08-18
Class II — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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FDA Device Recall: A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - 2021-01-27
Class II — The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increas...
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FDA Recall: Biomet, Inc. — Class II 20201223
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterilit | Product: 3.0mm Cannulated Screw System, BCS Can...
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FDA Recall: Biomet, Inc. — Class II 20201223
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterilit | Product: Comprehensive Total Shoulder System/Bi...
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FDA Recall: Biomet, Inc. — Class II 20201223
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterilit | Product: Oxford Fixed Lateral, Item numbers 154...
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FDA Recall: Biomet, Inc. — Class II 20201223
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterilit | Product: Custom Cancellous Thread, Item numbers...
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FDA Recall: Biomet, Inc. — Class II 20201014
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized | Product: Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 2...
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FDA Recall: Biomet, Inc. — Class II 20200603
Potential presence of elevated endotoxin levels that exceed the specification limit | Product: Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D
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FDA Recall: Biomet, Inc. — Class II 20200603
Potential presence of elevated endotoxin levels that exceed the specification limit | Product: Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees
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FDA Recall: Biomet, Inc. — Class II 20200415
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 ...
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FDA Recall: Biomet, Inc. — Class II 20200415
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 ...
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FDA Recall: Biomet, Inc. — Class II 20200415
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Product: BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item...
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FDA Recall: Biomet, Inc. — Class II 20200415
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 ...
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FDA Device Recall: Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intend 2020-12-30
Class II — Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
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FDA Device Recall: 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8. 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item num 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usag 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-4 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in lim 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended fo 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Produc 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1153 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6. 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 2020-12-23
Class II — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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FDA Device Recall: (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, 2020-10-21
Class II — Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not...
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FDA Device Recall: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adap 2020-10-21
Class II — Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) basepla...
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FDA Device Recall: Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 2020-10-14
Class II — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
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FDA Device Recall: Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 2020-10-14
Class II — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
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FDA Device Recall: Biomet Regenerex Primary Taper Cap Item Number 141269 2020-10-14
Class II — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
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FDA Device Recall: Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 2020-06-24
Class II — Device and tray that houses the device did not pass steam sterilization process validation testing
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FDA Device Recall: Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product 2020-06-24
Class II — Device and tray that houses the device did not pass steam sterilization process validation testing
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FDA Device Recall: A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Nu 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 11001796 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item N 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Nu 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Numbe 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Num 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Pr 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM 2020-06-17
Class II — Distributed to the field without having completed design history files or design transfer activities
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FDA Device Recall: Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00 2020-06-17
Class II — The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
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FDA Device Recall: Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construc 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 2 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Mode 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 M 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial T 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM St 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-11 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Pola 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex 2020-06-03
Class II — Potential presence of elevated endotoxin levels that exceed the specification limit
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FDA Device Recall: Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Num 2020-04-29
Class II — There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, It 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Sil 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, S 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Sil 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, St 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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FDA Device Recall: BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, It 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, St 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, S 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 4 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 4 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, It 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, It 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, S 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 2020-04-15
Class II — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
View Source
FDA Device Recall: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adap 2020-04-08
Class II — Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
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FDA Device Recall: Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants 2018-04-04
Class II — During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in...
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FDA Recall: Biomet, Inc. — Class II 20160601
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product | Product: Various trauma and sports medicine ins...
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FDA Recall: Biomet, Inc. — Class II 20160601
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. | Product: PerFuse Decompression Instrument PN: 800-0541, Lot:10065...
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FDA Recall: Biomet, Inc. — Class II 20160601
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product | Product: Various trauma and sports medicine ins...
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FDA Recall: Biomet, Inc. — Class II 20160601
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product | Product: Various trauma and sports medicine ins...
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FDA Recall: Biomet, Inc. — Class II 20160120
PMMA is listed as a material on the label but the product does not contain PMMA. | Product: Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm,
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Rod, fixation, int 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access t 2016-06-01
Class II — The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
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FDA Device Recall: Various trauma and sports medicine instruments and implants. Spinal interlamina 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Screw, fixation, b 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Arthroscope. 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Orthopedic manual 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. cannula, surgical, 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Reamer. 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Plate, fixation, b 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Fastener, fixation 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: Various trauma and sports medicine instruments and implants. Appliance, fixatio 2016-06-01
Class II — Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the produc...
View Source
FDA Device Recall: All instrumentation associated with the Prelude PF Resurfacing Knee System. 2016-04-13
Class II — Inadequate design control.
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FDA Device Recall: Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including 2016-03-16
Class II — Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the pro...
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FDA Device Recall: HipLOC CHS Plate/Lag Screw Introducer 2016-03-02
Class II — A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev...
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FDA Device Recall: Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9m 2016-01-20
Class II — PMMA is listed as a material on the label but the product does not contain PMMA.
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FDA Recall: Biomet, Inc. — Class II 20150715
The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on t | Product: A.L.P.S. Foot Locking Calcaneus Plate,...
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FDA Recall: Biomet, Inc. — Class II 20150708
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads | Product: Gentle Threads Interference Screw 9x35...
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FDA Recall: Biomet, Inc. — Class II 20150708
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads | Product: Gentle Threads Interference Screw 10x2...
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FDA Recall: Biomet, Inc. — Class II 20150617
Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too | Product: Unilateral external fixation ankle cla...
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FDA Device Recall: Black Mamba Suture Passer 2015-12-30
Class II — There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to ...
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FDA Device Recall: Green Mamba Suture Passer 2015-12-30
Class II — There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to ...
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FDA Device Recall: Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. 2015-09-09
Class II — The device was assembled without screw hole plugs.
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FDA Device Recall: A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw 2015-07-22
Class II — Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
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FDA Device Recall: A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic s 2015-07-15
Class II — The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back ou...
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FDA Device Recall: Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixati 2015-07-08
Class II — Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. ...
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FDA Device Recall: Gentle Threads Interference Screw 10x25mm Round Head. An interference fixatio 2015-07-08
Class II — Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. ...
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FDA Device Recall: Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. 2015-06-24
Class II — The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on ...
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FDA Device Recall: Unilateral external fixation ankle clamp Product Usage: Unilateral external 2015-06-17
Class II — Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. ...
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FDA Device Recall: Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al- 2015-06-17
Class III — Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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FDA Device Recall: Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD 2015-06-17
Class III — Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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FDA Device Recall: Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6 2015-06-17
Class III — Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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FDA Device Recall: MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 2015-06-17
Class III — Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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FDA Device Recall: LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provid 2015-04-22
Class II — A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print...
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FDA Device Recall: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapto 2015-03-04
Class II — The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
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FDA Device Recall: Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis compo 2015-02-25
Class II — Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the t...
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FDA Device Recall: Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. 2015-02-25
Class II — Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the t...
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FDA Device Recall: Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: 2014-12-24
Class II — After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cement...
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FDA Device Recall: Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identific 2014-12-24
Class II — After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cement...
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FDA Device Recall: Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety 2014-10-22
Class II — An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
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FDA Device Recall: Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are u 2014-10-15
Class II — An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
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FDA Device Recall: DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6 2014-07-02
Class II — Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requ...
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FDA Device Recall: EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual 2014-06-25
Class II — The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
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FDA Device Recall: EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunctio 2014-06-25
Class II — The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
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FDA Device Recall: Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biome 2014-03-26
Class II — Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
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FDA Device Recall: G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 2014-01-01
Class II — Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly correspond...
View Source
FDA Recall: Biomet, Inc. — Class II 20130717
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing compo | Product: REF 154216 Oxford Fixed Bearing Partia...
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FDA Recall: Biomet, Inc. — Class II 20130717
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing compo | Product: REF 154211 Oxford Fixed Bearing Partia...
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FDA Recall: Biomet, Inc. — Class II 20130717
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing compo | Product: REF 154225Oxford Fixed Bearing Partial...
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FDA Recall: Biomet, Inc. — Class II 20130717
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing compo | Product: REF 154215 Oxford Fixed Bearing Partia...
View Source
FDA Recall: Biomet, Inc. — Class II 20130717
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing compo | Product: REF 154229 Oxford Fixed Bearing Partia...
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FDA Recall: Biomet, Inc. — Class II 20130626
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. W | Product: Superior Approach Resection Guide Asse...
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FDA Recall: Biomet, Inc. — Class II 20130116
Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be | Product: PT113950 PT HYBRID Glenoid Post Regen...
View Source
FDA Device Recall: REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Sta 2013-12-04
Class II — Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
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FDA Device Recall: REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARC 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARC 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARC 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
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FDA Device Recall: REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 AR 2013-07-17
Class II — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
View Source
FDA Device Recall: Superior Approach Resection Guide Assembly. Indicated for primary, fracture, 2013-06-26
Class II — Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is ...
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FDA Device Recall: Active Articulation E1. Intended for use with either primary or revision hip 2013-06-12
Class II — Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D...
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FDA Device Recall: REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthoped 2013-03-20
Class II — The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto ...
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FDA Device Recall: TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufac 2013-02-06
Class II — Thru hole at the tip of the screw is undersized.
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FDA Device Recall: PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R 2013-01-16
Class II — Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition ca...
View Source
FDA Device Recall: EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail Syst 2012-12-26
Class II — It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
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FDA Device Recall: Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product 2012-12-26
Class II — Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible d...
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FDA Device Recall: Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) 2012-12-12
Class II — The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the p...
View Source
FDA Device Recall: OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS S 2012-12-12
Class II — Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
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FDA Device Recall: Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Pl 2012-10-10
Class II — Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material ...
View Source
ftc_enforcement 1 records
Zimmer Holdings, Inc. / Biomet, Inc., In the Matter of 2015-08-20
FTC live enforcement action FY2015; matched respondent 'Biomet, Inc., In the Matter of'
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lobbying 1 records
Lobbying Firm: BIOMET, INC.
Registered lobbying firm — Warsaw, IN — Designs, manufactures & markets products used primarily by orthopedic medical specialists.
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ny_corps 1 records
NY Corp: BIOMET, INC. 1993-02-08
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Indiana
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sec_litigation 1 records
SEC Litigation: Biomet, Inc. 2012-03-26
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