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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 INBONEsee related information
Date Initiated by FirmSeptember 30, 2022
Date PostedOctober 27, 2022
Recall Status1 Terminated 3 on August 21, 2026
Recall NumberZ-0140-2023
Recall Event ID 90965
510(K)NumberK051023 
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
ProductStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Code Information GTIN 00840420124159, Lot Code: 1725563
FEI Number 3010667733
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information ContactMeghan Wells
901-201-9298
Manufacturer Reason
for Recall		The tibial tray lock detail is oversized (larger than specification).
FDA Determined
Cause 2		Device Design
ActionStryker 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 Commerce1 unit
DistributionUS Nationwide distribution in the state of New York.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = HSN
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