Howmedica Osteonics TS Misc. Instruments Tray Triathlon recalled for insufficient sterilization drying time
What this means
Howmedica Osteonics TS Misc. Instruments Tray (Triathlon, catalog 6543-6-519) has reprocessing instructions that specify a 30-minute dry time after sterilization when using blue wrap. This dry time may not be long enough, potentially leaving small amounts of moisture on the trays after sterilization. Affected trays were distributed to hospitals and surgical centers.
- If you use this tray model, check the reprocessing instructions for the correct sterilization dry time with blue wrap.
- Contact Howmedica Osteonics or your distributor for updated reprocessing guidance.
- Do not use affected trays until you have confirmed the correct sterilization protocol.
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-0167-2027More Howmedica Osteonics recalls
- FDA-Device2026-10-21Howmedica Osteonics TS Femoral Prep Tray recalled for inadequate sterilization dry time instructions
- 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
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