INFINITY recallZ-1291-2022 · Wright Medical Technology, Inc. · initiated Jun 2, 2022
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 instrument is incorrectly color coded.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued letters dated 2-June-2022 via email. The letter was issued to the distributors but the noticed was flagged to the attention of health care professionals, operators of medical devices, and distributors. The letter provided the product description, issue, potential risks, and actions needed as follows: (1) Immediately check the inventory to locate the product listed on the attached business reply form and remove it from its point of use; (2) Return the enclosed business reply form by email to confirm receipt of this notification and document product segregation; (3) Upon receipt of the completed business reply form, Stryker will contact the consignee to arrange for the return and replacement of the product; (4) Maintain awareness of this communication internally until all required actions have been completed within the consignee facility; (5) If the product has been further distributed, notify all affected parties at once about the recall. A copy of this notification can be used to send to the consignees. If possible, the recalling firm should be informed if any of the devices have been further distributed, including contact details, so that the recalling firm can inform the recipients appropriately. If the consignee first receiving the letter is a distributor, they are responsible for notifying their affected customers.
Recall details
- Recall number
- Z-1291-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2022
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 35 units
- Product code
- HSN
- FDA submissions
- K140749
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
Product description
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Code information (models, lots, serial numbers)
Lot #2039558, GTIN 00889797006552.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INFINITY 33620254Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
Product lines
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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