INBONE recallZ-0140-2023 · Wright Medical Technology, Inc. · initiated Sep 30, 2022
Terminated
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 tibial tray lock detail is oversized (larger than specification).
FDA root cause category: Device Design
What the company is doing
Stryker notified consignees on about 09/30/2022, via letter that was hand delivered or sent via email titled, "URGENT: MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory and quarantine any affected product, return the enclosed response form, arrange for the return of affected product and notify all applicable parties of the recall if product was further distributed.
Recall details
- Recall number
- Z-0140-2023
- Status
- Terminated
- Initiated by the company
- Sep 30, 2022
- Posted by the FDA
- Oct 27, 2022
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 1 unit
- Product code
- HSN
- FDA submissions
- K051023
- Distribution
- US Nationwide distribution in the state of New York.
Product description
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Code information (models, lots, serial numbers)
GTIN 00840420124159, Lot Code: 1725563
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INBONE 200252904Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90965).
- Z-0139-2023 · TerminatedStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
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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