INFINITY recallZ-1477-2024 · Wright Medical Technology, Inc. · initiated Mar 6, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wright Medical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
FDA root cause category: Process change control
What the company is doing
Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/06/2024 via email. The notice explained the issue, potential risk, and requested the consignee isolate/quarantine the affected product pending return of the device. If the affected product was further distributed, please notify the applicable parties at once about this recall. This notification letter may be copied and distributed. a. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. For questions or concerns, please contact [email protected].
Recall details
- Recall number
- Z-1477-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 6, 2024
- Posted by the FDA
- Apr 4, 2024
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 47 units
- Product code
- HSN
- FDA submissions
- K123954
- Distribution
- US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Product description
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Code information (models, lots, serial numbers)
UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INFINITY 33600030Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K123954 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- INFINITY™ ADAPTIS™ 33680143Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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