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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker INBONE

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  Class 2 Device Recall Stryker INBONE see related information
Date Initiated by Firm September 30, 2022
Date Posted October 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-0140-2023
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/ 18mm Stem Base, REF 200252904, Size 4
Code Information GTIN 00840420124159, Lot Code: 1725563
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 2		 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 and Original Applicant = TOPEZ ORTHOPEDICS, INC
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