Department of Justice
1 records
DOJ: Exactech Agrees to Pay $8 Million to Resolve False Claims Act Allegations for Selling Defective Knee Implant Devices
2025-09-16
...company violated the federal False Claims Act. A medical device company based...Exactech allegedly violated the False Claims Act by knowingly submitting or causing...to Pay $8 Million to Resolve Fa...
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fda
162 records
FDA Device Recall: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Cat
2026-03-18
Class II — Impactor handle may be missing cross-pin
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FDA Device Recall: Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Mod
2025-11-26
Class II — Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
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FDA Device Recall: Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM
2025-09-24
Class II — Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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FDA Device Recall: AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28M
2025-02-19
Class II — Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
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FDA Device Recall: Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00
2025-02-19
Class II — Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
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FDA Recall: Exactech, Inc. — Class II
20240410
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They | Product: Exactech Equinoxe GLENOID,POSTERIOR AU...
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FDA Recall: Exactech, Inc. — Class II
20240410
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They | Product: Exactech Equinoxe GLENOID, POSTERIOR A...
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FDA Device Recall: OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 2
2024-06-26
Class II — Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
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FDA Device Recall: OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29,
2024-06-26
Class II — Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
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FDA Device Recall: Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED US
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 32
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Sho
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47,
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with:
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Size
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta cur
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, I
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta cur
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:
2024-04-10
Class II — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did ...
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FDA Device Recall: AcuMatch Hip System, Catalog Number 142-32-27
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Novation Hip System, Catalog Numbers: 134-36-45
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-03
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29,
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-02
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029,
2023-12-27
Class II — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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FDA Device Recall: Exactech Ergo Impactor Handle, Catalog #321-09-05.
2023-07-05
Class II — The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
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FDA Recall: Exactech, Inc. — Class II
20220921
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | Product: GXL acetabular liners, orthopedic hip impla...
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Device Recall: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
2022-09-21
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Recall: Exactech, Inc. — Class II
20210728
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla | Product: Exactech Connexion GXL acetabular poly...
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FDA Device Recall: OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OP
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components.
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene L
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the foll
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: OPTETRAK Comprehensive Knee System custom devices labeled as the following:
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK Al
2021-10-13
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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FDA Device Recall: Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosth
2021-08-18
Class II — Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
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FDA Device Recall: Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis com
2021-08-18
Class II — Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Exactech Connexion GXL acetabular polyethylene liners used in the following syst
2021-07-28
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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FDA Device Recall: Equinoxe Humeral Stem, Primary, Press Fit, 11mm
2021-01-27
Class II — Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
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FDA Recall: Exactech, Inc. — Class II
20200909
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Tota | Product: The Vantage Total Ankle Tibial Insert,...
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FDA Device Recall: Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
2020-11-25
Class II — The product may be mislabeled.
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FDA Device Recall: Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platf
2020-11-04
Class II — The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
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FDA Device Recall: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
2020-10-07
Class II — Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
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FDA Device Recall: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
2020-10-07
Class II — Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
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FDA Device Recall: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
2020-09-09
Class II — The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, S...
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FDA Device Recall: Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are u
2020-03-04
Class II — These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when th...
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FDA Device Recall: Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF
2020-02-05
Class II — Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other th...
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FDA Device Recall: Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 3
2020-02-05
Class II — Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other th...
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FDA Recall: Exactech, Inc. — Class II
20190306
Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather t | Product: Equinoxe Preserve Humeral Stem, 8mm ...
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FDA Device Recall: Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
2019-06-05
Class II — The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equi...
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FDA Device Recall: Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
2019-06-05
Class II — The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equi...
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FDA Device Recall: Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
2019-06-05
Class II — The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equi...
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FDA Device Recall: Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Ste
2019-03-06
Class II — Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem...
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FDA Recall: Exactech, Inc. — Class II
20180926
Potentially have non-conforming internal threads. | Product: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicat
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FDA Device Recall: Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shou
2018-10-10
Class II — The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
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FDA Device Recall: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Kn
2018-09-26
Class II — Potentially have non-conforming internal threads.
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FDA Device Recall: Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for
2018-09-12
Class II — Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Constrained Condylar Offset S...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Offset Tibial Tray and Screws...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Constrained Condylar Offset S...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Constrained Condylar Offset S...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Offset Tibial Tray and Screws...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Offset Tibial Tray and Screws...
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FDA Recall: Exactech, Inc. — Class II
20171129
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in co | Product: Optetrak Constrained Condylar Offset S...
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FDA Recall: Exactech, Inc. — Class II
20170712
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement th | Product: EXACTECH Equinoxe Narrow Modular Rever...
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FDA Device Recall: Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech
2017-12-13
Class II — Possible inner labeling and packaged device not matching the outer label on the box.
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FDA Device Recall: Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech I
2017-12-13
Class II — Possible inner labeling and packaged device not matching the outer label on the box.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22,
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Steril
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Steril
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Steril
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Steril
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, S
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, S
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, St
2017-11-29
Class II — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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FDA Device Recall: Exactech Optetrak Logic CC 15mm Tibial Augment Screws
2017-07-19
Class II — Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
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FDA Device Recall: EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321
2017-07-12
Class II — Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and ...
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FDA Device Recall: EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalo
2017-07-12
Class II — Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and ...
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FDA Device Recall: EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-
2017-07-12
Class II — Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and ...
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FDA Device Recall: Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the i
2017-07-05
Class II — The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a c...
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FDA Device Recall: AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 m
2017-01-25
Class II — Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
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FDA Device Recall: Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
2017-01-25
Class II — Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
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FDA Device Recall: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral
2016-07-13
Class II — Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
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FDA Device Recall: Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem,
2016-06-08
Class II — Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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FDA Device Recall: Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular C
2016-06-08
Class II — Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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FDA Device Recall: Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral St
2016-06-08
Class II — Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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FDA Recall: Exactech, Inc. — Class II
20150722
Incorrect thread form on the screw. | Product: Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to p
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FDA Device Recall: Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Si
2015-11-11
Class II — Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
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FDA Device Recall: Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS051
2015-07-22
Class II — Incorrect thread form on the screw.
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FDA Device Recall: Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpower
2015-07-22
Class II — Shipped to a single consignee prior to completion of final inspection.
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FDA Device Recall: Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Pla
2015-07-22
Class II — Shipped to a single consignee prior to completion of final inspection.
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FDA Device Recall: Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic sh
2015-04-29
Class II — Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
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FDA Device Recall: NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catal
2014-07-30
Class II — The femoral stem is lacking specified plasma coating.
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FDA Device Recall: ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm She
2014-02-12
Class II — Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
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FDA Device Recall: Exactech Articulated Driver A nonpowered hand-held device intended for medic
2013-08-07
Class II — When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
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FDA Device Recall: Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE,
2013-02-13
Class II — Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discover...
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FDA Device Recall: Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL
2013-02-13
Class II — Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discover...
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FDA Recall: Exactech, Inc. — Class II
20120808
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter T | Product: Octane-C Cervical, 6¿ Lordotic Intend...
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FDA Device Recall: REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use wi
2012-09-19
Class II — Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
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FDA Device Recall: REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use wi
2012-09-19
Class II — Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
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FDA Device Recall: REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use wi
2012-09-19
Class II — Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
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FDA Device Recall: OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YEL
2012-09-12
Class II — Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.
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FDA Device Recall: OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***S
2012-08-29
Class II — Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial...
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FDA Device Recall: Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interverteb
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse T
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Sho
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Sho
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary an
2012-08-08
Class II — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral...
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FDA Device Recall: Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED*
2012-08-01
Class II — Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray...
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FDA Device Recall: Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***T
2012-08-01
Class II — Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray...
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ny_corps
1 records
NY Corp: EXACTECH, INC.
1990-12-10
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Florida
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