Howmedica Osteonics Corp. — Class II: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Howmedica Osteonics Corp. initiated a Class II recall for the TS Universal Baseplate Finishing Tray due to inadequate reprocessing instructions. The provided 30-minute sterilization dry time for trays using blue wrap may result in residual moisture remaining after the process.
Healthcare facilities using the Triathlon TS Universal Baseplate Finishing Tray, sterile processing departments, and regulatory professionals managing orthopedic instrument sterilization protocols.
Residual moisture following sterilization can compromise the sterile barrier and increase the risk of microbial contamination. This recall suggests that existing validated dry times for large orthopedic trays may require reassessment when specific containment methods, such as blue wrap, are employed. Regulatory teams may need to evaluate whether similar drying time discrepancies exist across related instrument portfolios.
Review and validate reprocessing instructions for reusable instrument trays, specifically focusing on dry time parameters when using blue wrap sterilization methods. Quality teams should assess if existing IFUs (Instructions for Use) result in residual moisture and initiate updates or user notifications as necessary.
Class II. Reason: 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.. Product: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.. Firm: Howmedica Osteonics Corp. (Mahwah NJ United States). Status: Ongoing.
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