Z-0140-2023 Class II Terminated
FDA device recall Z-0140-2023 was initiated by Wright Medical Technology, Inc. on September 30, 2022 and is designated Class II. Reason for recall: The tibial tray lock detail is oversized (larger than specification). The recall status is terminated (terminated August 21, 2026). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- August 21, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Reason for Recall
The tibial tray lock detail is oversized (larger than specification).
Distribution Pattern
US Nationwide distribution in the state of New York.
Code Information
GTIN 00840420124159, Lot Code: 1725563