Howmedica Osteonics TS Femoral Prep Tray recalled for inadequate sterilization dry time instructions
What this means
Howmedica Osteonics Corp. is recalling the TS Femoral Prep Tray, Triathlon (Catalog Number 6543-6-507) due to incorrect reprocessing instructions. The instructions specify a 30-minute dry time after sterilization in blue wrap, which may not be long enough to eliminate all residual moisture, potentially compromising the sterility of the trays.
- If you use this tray, contact Howmedica Osteonics Corp. or your distributor for corrected sterilization instructions.
- Do not use trays sterilized with the 30-minute dry time until you have confirmed the correct reprocessing procedure.
- Review lot numbers distributed prior to May 8, 2026, to identify affected inventory.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2027More Howmedica Osteonics recalls
- FDA-Device2026-10-21Howmedica Osteonics TS Misc. Instruments Tray Triathlon recalled for insufficient sterilization drying time
- FDA-Device2026-10-21Howmedica Osteonics Triathlon Hinge Femoral Prep Tray recalled for inadequate sterilization instructions
- FDA-Device2026-10-21Howmedica Osteonics TS Universal Baseplate Finishing Tray recalled for residual moisture after sterilization
- FDA-Device2026-09-23Howmedica Osteonics elbow implant axle pin recalled for premature wear and fracture risk
- FDA-Device2026-09-23Howmedica Osteonics Triathlon Hinge Insert recalled for premature wear risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.