Howmedica Osteonics TS Universal Baseplate Finishing Tray recalled for residual moisture after sterilization
What this means
The sterilization instructions for Howmedica Osteonics TS Universal Baseplate Finishing Trays (used in orthopedic surgery) may not allow enough drying time when blue wrap is used. This could leave small amounts of moisture on the trays after sterilization, which may affect their sterility.
- If you use this tray (catalog number 6543-6-506), check the lot number on your supply.
- Contact your Howmedica Osteonics distributor or the company directly for updated sterilization instructions.
- Do not use affected trays until you receive corrected reprocessing 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-0164-2027More Howmedica Osteonics recalls
- FDA-Device2026-10-21Howmedica Osteonics TS Misc. Instruments Tray Triathlon recalled for insufficient sterilization drying time
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- FDA-Device2026-10-21Howmedica Osteonics Triathlon Hinge Femoral Prep Tray recalled for inadequate sterilization instructions
- 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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