Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
FDA Recall Z-0140-2023 · Posted 2022-10-27
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Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHSN
Date Initiated2022-09-30
Date Terminated2026-08-21
Product Quantity1 unit
Reason for Recall
The tibial tray lock detail is oversized (larger than specification).
Firm Action
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
Distribution Pattern
US Nationwide distribution in the state of New York.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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