Howmedica Osteonics Triathlon Hinge Femoral Prep Tray recalled for inadequate sterilization instructions
What this means
Howmedica Osteonics issued updated reprocessing instructions for the Triathlon Hinge Femoral Prep Tray (catalog 6543-6-514) because the previous sterilization dry time of 30 minutes—when blue wrap is used—may not be long enough to fully dry the trays. Residual moisture could remain after sterilization, potentially affecting the tray's safety or performance in surgery.
- If your facility uses this tray, contact Howmedica Osteonics or your distributor for updated reprocessing instructions before further use.
- Follow the revised sterilization dry time in the new instructions (LSTPI-B).
- Do not use trays sterilized under the old 30-minute dry-time protocol until you have confirmed compliance with updated guidance.
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-0166-2027More Howmedica Osteonics recalls
- FDA-Device2026-10-21Howmedica Osteonics TS Misc. Instruments Tray Triathlon recalled for insufficient sterilization drying time
- FDA-Device2026-10-21Howmedica Osteonics TS Femoral Prep Tray recalled for inadequate sterilization dry time 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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