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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Device Recall Strykersee related information
Date Initiated by FirmJuly 30, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3196-2026
Recall Event ID 99558
510(K)NumberK850352 K900438 
Product Classification Prosthesis, hip, semi-constrained (metal cemented acetabular component) - Product Code JDL
ProductOMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Code Information UDI-DI 07613327037883 Lot 13MFT
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactEvelyn Ryan
201-831-5000
Manufacturer Reason
for Recall		Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
FDA Determined
Cause 2		Process change control
ActionFirm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.
Quantity in Commerce12,156 US
DistributionWorldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
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 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) Database510(K)s with Product Code = JDL
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