Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Triathlon Hinge Femoral Prep Tray
- Catalog Number6543-6-514
- Lot codes and dates
- Catalog Number6543-6-514
- GTIN07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted
- Amount recalled
- 359 trays
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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