courtlistener_docket
7 records
Wodarczyk v. Stryker Corporation
2026-05-28
Federal docket 1:26-cv-06281 (ilnd); matched party 'Stryker Corporation'
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Honas v. Stryker Corporation
2026-05-15
Federal docket 1:26-cv-12233 (mad); matched party 'Stryker Corporation'
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Emzika v. Stryker Corporation
2026-05-11
Federal docket 1:26-cv-01559 (miwd); matched party 'Stryker Corporation'
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Stryker Corporation v. Dunn
2026-05-08
Federal docket 1:26-cv-01534 (miwd); matched party 'Stryker Corporation'
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Honas v. Stryker Corporation
2026-04-16
Federal docket 1:26-cv-01636 (cod); matched party 'Stryker Corporation'
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Tanner v. Stryker Corporation
2026-03-31
Federal docket 1:26-cv-01064 (miwd); matched party 'Stryker Corporation'
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Primer v. Stryker Corporation
2026-03-27
Federal docket 1:26-cv-01026 (miwd); matched party 'Stryker Corporation'
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fda
155 records
FDA Device Recall: MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 1
2026-02-25
Class II — Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
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FDA Recall: Stryker Corporation — Class II
20250409
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, | Product: Otopore Cylinder outer ear wound dress...
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FDA Recall: Stryker Corporation — Class II
20250409
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, | Product: Nasopore FD fragmentable nasal dressin...
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FDA Recall: Stryker Corporation — Class II
20250409
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, | Product: Otopore Square outer ear wound dressin...
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FDA Recall: Stryker Corporation — Class II
20250409
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, | Product: Hemopore 8cm nasal/sinus temporary wou...
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FDA Recall: Stryker Corporation — Class II
20250319
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. | Product: Stryker CinchLock Flex Knotless Anchor wi...
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FDA Recall: Stryker Corporation — Class II
20250129
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package | Product: stryker 3.0MM Neuro Match Head, REF 58...
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FDA Device Recall: NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Ho
2025-12-03
Class II — Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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FDA Device Recall: NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN
2025-12-03
Class II — Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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FDA Device Recall: Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Dispo
2025-07-30
Class II — Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
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FDA Device Recall: Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
2025-06-18
Class II — Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contain...
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FDA Device Recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog
2025-06-18
Class II — Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
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FDA Device Recall: Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
2025-06-18
Class II — Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contain...
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FDA Device Recall: Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-0
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Fo
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-0
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and F
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 an
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 an
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and F
2025-04-09
Class II — There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the steri...
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FDA Device Recall: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, S
2025-03-19
Class II — Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
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FDA Device Recall: stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and S
2025-02-19
Class II — Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
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FDA Device Recall: stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone ceme
2025-01-29
Class II — There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice...
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FDA Device Recall: stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and
2025-01-29
Class II — There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice...
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FDA Device Recall: The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used
2025-01-29
Class II — There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
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FDA Recall: Stryker Corporation — Class II
20241120
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Un | Product: Stryker Neptune SafeAir Rocker-Switch ...
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FDA Recall: Stryker Corporation — Class II
20241120
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Un | Product: Stryker Neptune SafeAir Smoke Evacuati...
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FDA Recall: Stryker Corporation — Class II
20241120
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Un | Product: Stryker Neptune SafeAir Rocker-Switch ...
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FDA Recall: Stryker Corporation — Class II
20240904
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than spe | Product: Stryker iBur 3.0mm Coarse Diamond Roun...
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FDA Recall: Stryker Corporation — Class II
20240904
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than spe | Product: Stryker iBur 2.0mm Diamond Round, Dist...
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FDA Recall: Stryker, Inc. — Class II
20240221
The microcatheter IFU contains an intended use that has not been evaluated by the FDA. | Product: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
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FDA Recall: Stryker, Inc. — Class II
20240221
The microcatheter IFU contains an intended use that has not been evaluated by the FDA. | Product: Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
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FDA Device Recall: Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - De
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Butt
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-S
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-ste
2024-11-20
Class II — There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device ma...
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FDA Device Recall: Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the foll
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the fol
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the foll
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the fo
2024-09-04
Class II — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential fo...
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FDA Device Recall: The Non-Sterile Flyte hood covers the user s head and neck region and is intende
2024-07-10
Class II — Expired Products distributed to customers
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FDA Device Recall: Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann L
2024-07-03
Class II — The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
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FDA Device Recall: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
2024-02-21
Class II — The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
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FDA Device Recall: Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
2024-02-21
Class II — The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
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FDA Recall: Stryker Corporation — Class II
20231115
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the produ | Product: Disposable Spetzler-Malis Bipolar forc...
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FDA Recall: Stryker Corporation — Class II
20231115
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the produ | Product: Disposable Spetzler-Malis Bipolar forc...
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FDA Recall: Stryker Corporation — Class II
20230927
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to t | Product: Stryker ACM (Advanced Cement Mixing) S...
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FDA Recall: Stryker Corporation — Class II
20230412
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up | Product: Stryker Color Cuff Non-Sterile Disposa...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable
2023-11-15
Class II — Expired product distributed
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
View Source
FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
View Source
FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
View Source
FDA Device Recall: Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catal
2023-11-15
Class II — An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 yea...
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FDA Device Recall: Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
2023-10-04
Class II — Expired Product distributed
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway F
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle
2023-09-27
Class II — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of th...
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FDA Device Recall: SurgiCount+ Software Application-indicated as an adjunctive technology for augme
2023-09-06
Class II — Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
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FDA Device Recall: SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5
2023-05-10
Class II — Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
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FDA Device Recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PR
2023-04-12
Class II — Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead...
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FDA Device Recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PR
2023-04-12
Class II — Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead...
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FDA Device Recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1P
2023-04-12
Class II — Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead...
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FDA Device Recall: Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the est
2023-03-08
Class II — Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in eithe...
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FDA Device Recall: Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Ca
2023-03-08
Class II — Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in eithe...
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FDA Device Recall: Smart Toe II Intramedullary Arthrodesis Implant
2022-05-04
Class II — The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not ...
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FDA Device Recall: 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general lapa
2022-03-16
Class II — A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open proce...
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FDA Device Recall: Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Cata
2021-08-11
Class II — The devices have a different inner diameter than the diameter specified on the outer box label.
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FDA Device Recall: Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD M
2021-04-21
Class II — Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
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FDA Recall: Stryker GmbH — Class II
20200624
Seal integrity of the blister pack may be compromised and sterility cannot be assured | Product: Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker im
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FDA Device Recall: Osteosynthesis Compression Staple EasyClip
2020-11-25
Class II — The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
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FDA Device Recall: Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Produ
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: St
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Str
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896504
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 189
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Pro
2020-06-24
Class II — Seal integrity of the blister pack may be compromised and sterility cannot be assured
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FDA Device Recall: Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Dr
2020-05-13
Class II — Sterile drapes packaged in an unsealed pouch.
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FDA Device Recall: Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement,
2020-03-25
Class II — Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could res...
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FDA Device Recall: Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471,
2020-02-19
Class II — Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This co...
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FDA Device Recall: Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-50
2020-02-19
Class II — Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This co...
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FDA Device Recall: Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instrument
2020-01-15
Class II — Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
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FDA Device Recall: Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin
2020-01-15
Class II — Pin To Rod Coupling could not clamp the pin and rod as intended
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FDA Recall: Stryker GmbH — Class II
20190904
The seal integrity of the sterile bag containing the kits may be compromised. | Product: Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of pl
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FDA Recall: Stryker GmbH — Class II
20190904
The seal integrity of the sterile bag containing the kits may be compromised. | Product: Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment
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FDA Recall: Stryker GmbH — Class II
20190904
The seal integrity of the sterile bag containing the kits may be compromised. | Product: Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment
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FDA Recall: Stryker Corporation — Class II
20190612
The heated tube sets were consistently leaking and detaching from the cassette. | Product: Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insuffla
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FDA Recall: Stryker GmbH — Class II
20190313
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. | Product: Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Kn...
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FDA Device Recall: Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designe
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
View Source
FDA Device Recall: Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designe
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is des
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system i
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
View Source
FDA Device Recall: Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is de
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
View Source
FDA Device Recall: Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed f
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
View Source
FDA Device Recall: Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is design
2019-09-04
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
2019-06-26
Class II — The seal integrity of the sterile bag containing the kits may be compromised.
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FDA Device Recall: Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SUR
2019-06-12
Class II — The heated tube sets were consistently leaking and detaching from the cassette.
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FDA Device Recall: Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-6
2019-06-12
Class II — The heated tube sets were consistently leaking and detaching from the cassette.
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FDA Device Recall: Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: K
2019-03-13
Class II — The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
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FDA Recall: Stryker GmbH — Class II
20181107
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore | Product: Hoffman LRF Hexapod Strut, Extra Short...
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FDA Recall: Stryker GmbH — Class II
20180718
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may | Product: Femoral Nail, A/R T2 Femur ¿10x320 mm,...
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FDA Recall: Stryker GmbH — Class II
20180718
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may | Product: Ankle Arthrodesis Nail, right T2 Ankle...
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FDA Recall: Stryker GmbH — Class II
20180718
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may | Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x...
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FDA Recall: Stryker Corporation — Class II
20180314
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | Product: STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 02...
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FDA Device Recall: Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Pro
2018-11-07
Class II — The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a...
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FDA Device Recall: Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Pro
2018-11-07
Class II — The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a...
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FDA Device Recall: Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Pro
2018-11-07
Class II — The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a...
View Source
FDA Device Recall: Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF
2018-10-03
Class II — When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an err...
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FDA Device Recall: Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
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FDA Device Recall: Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
View Source
FDA Device Recall: Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
View Source
FDA Device Recall: Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
View Source
FDA Device Recall: Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
2018-07-18
Class II — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength an...
View Source
FDA Device Recall: Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
2018-06-27
Class II — Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
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FDA Device Recall: 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box.
2018-06-13
Class II — Inadvertent shipment of expired units.
View Source
FDA Device Recall: Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fra
2018-05-02
Class II — The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
View Source
FDA Device Recall: CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based men
2018-03-21
Class II — The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
View Source
FDA Device Recall: STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model
2018-03-14
Class II — Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
View Source
FDA Device Recall: STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following:
2018-03-14
Class II — Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
View Source
FDA Device Recall: Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter
2016-06-15
Class II — Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction
View Source
FDA Device Recall: CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthoped
2016-05-18
Class II — Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment...
View Source
lobbying
5 records
Lobbying Client: STRYKER CORPORATION
Lobbied by BAKER & HOSTETLER LLP — medical technology
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Lobbying Client: STRYKER CORPORATION
Lobbied by THORN RUN PARTNERS — Medical Technologies Corporation
View Source
Lobbying Client: STRYKER CORPORATION
Lobbied by THORN RUN PARTNERS — Medical Technologies Corporation
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Lobbying Client: STRYKER CORPORATION
Lobbied by THORN RUN PARTNERS — Medical Technologies Corporation
View Source
ny_corps
1 records
NY Corp: STRYKER CORPORATION
2010-10-21
FOREIGN BUSINESS CORPORATION | County: Erie | Jurisdiction: Michigan
View Source
SEC EDGAR
1 records
sec_efts
1 records
SEC Filing: STRYKER CORP
2026-03-12
SEC EDGAR filing — Forms: 8-K — Query: cybersecurity
View Source
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