INFINITY recallZ-2105-2023 · Wright Medical Technology, Inc. · initiated Jun 13, 2023
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
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
FDA root cause category: Process control
What the company is doing
The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of the notification and document product segregation. Upon receipt of the reply form, Stryker will contact the consignee for return of the product. If the devices have been distributed to other organizations, contact details are requested so that Stryker can inform the recipients appropriately. If the consignee is a distributor, they are responsible for notifying their affected customers. An undated recall letter accompanied the FSCA that will be issued once the lead competent authority approves it. The content of the letter was similar to the FSCA and contained a business reply form.
Recall details
- Recall number
- Z-2105-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 13, 2023
- Posted by the FDA
- Jul 7, 2023
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 106 devices
- Product code
- HSN
- FDA submissions
- K123954
- Distribution
- There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Product description
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Code information (models, lots, serial numbers)
Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 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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