Class IIDeviceOngoing

Howmedica Osteonics Corp.

Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.

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.

Details

Recall number: Z-0166-2027
Event ID: 99883
Recall initiated: Sep 16, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 359 trays
Distribution: These 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Mahwah, NJ, United States
Lot / code info: Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.