TemporaryFDAOngoing
Can cause harm that is usually temporary.
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Check the device or its packaging for
Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
- Why
- 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.
- Distributed
- 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.
- Company
- Howmedica Osteonics Corp.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0166-2027 · retrieved 15 October 2026
Read the official notice