Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
FDA device recall Z-0140-2023 · posted 2022-10-27 · Open, Classified
Recall details
- Recalling firm
- Wright Medical Technology, Inc.
- Reason for recall
- The tibial tray lock detail is oversized (larger than specification).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HSN
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of New York.
- Date initiated
- 2022-09-30
- Date posted
- 2022-10-27
- Location
- Memphis, TN
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| TOPEZ TOTAL ANKLE REPLACEMENT (K051023) | Topez Orthopedics, Inc. | 2005-11-15 |