Class 2 Device Recall Stryker INBONE

• Date Initiated by Firm: September 30, 2022
• Date Posted: October 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0139-2023
• Recall Event ID: 90965
• 510(K)Number: K051023
• Product Classification: Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
• Product: Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
• Code Information: GTIN 00840420124142, Lot Code: 1726308
• FEI Number: 3010667733
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 1023 Cherry Rd; Memphis TN 38117-5423
• For Additional Information Contact: Meghan Wells; 901-201-9298
• Manufacturer Reason for Recall: The tibial tray lock detail is oversized (larger than specification).
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of New York.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HSN