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U.S. Department of Health and Human Services

Class 2 Device Recall TRI TS BASEPLATE SIZE 4

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 Class 2 Device Recall TRI TS BASEPLATE SIZE 4see related information
Date Initiated by FirmMay 19, 2026
Date PostedJune 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2462-2026
Recall Event ID 99080
510(K)NumberK123486 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
ProductTRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Code Information Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactRachel Seligman
201-831-5000
Manufacturer Reason
for Recall		Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker notified consignees on about 05/19/2026 via letter sent using FedEx 2-day service. Consignees were instructed to inform users of the Urgent Medical Device Recall and forward the notice to all individuals who need to be made aware or organizations who have consigned product, immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are on hand, and complete and return the provided Urgent Medical Device Recall Business Reply Form.
Quantity in Commerce7 units
DistributionUS Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
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 = MBH
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