RecallDepth

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

Company
Wright Medical Technology, Inc.
Recall Initiated
September 30, 2022
Posted
October 27, 2022
Recall Number
Z-0140-2023
Quantity
1 unit
Firm Location
Memphis, TN

Reason for Recall

The tibial tray lock detail is oversized (larger than specification).

Distribution

US Nationwide distribution in the state of New York.

Lot / Code Info

GTIN 00840420124159, Lot Code: 1725563

Root Cause

Device Design

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.

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