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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Hinge Femoral Prep Tray

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 Class 2 Device Recall Triathlon Hinge Femoral Prep Traysee related information
Date Initiated by FirmSeptember 16, 2026
Date PostedOctober 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0166-2027
Recall Event ID 99883
Product Classification Tray, surgical, instrument - Product Code FSM
ProductTriathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Code Information Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactAnum Bartolotta
201-831-5000
Manufacturer Reason
for Recall		Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
FDA Determined
Cause 2		Labeling design
ActionStryker notified consignees on about 09/16/2026 via "MEDICAL DEVICE CORRECTION" letter mailed through UPS 2-day air. Consignees were informed that reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes, however, these trays require a sterilization dry time of 40 minutes when sterilized in blue wrap. Consignees were instructed to inform users of the Medical Device Correction and forward the notice to all individuals who need to be made aware or organizations who have consigned product, review and follow the updated instructions provided in LSTPI-B Cleaning, Sterilization, Inspection, and Maintenance of Reusable Medical Devices Reference Guide, complete and return the provided Medical Device Correction Business Reply Form.
Quantity in Commerce359 trays
DistributionThese trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
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.
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