Howmedica Osteonics Corp. — Class II: Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics Corp. has initiated a Class II recall for the Triathlon Hinge Femoral Prep Tray due to a potential inadequacy in sterilization dry time instructions. When sterilized using blue wrap, the specified 30-minute dry time may result in residual moisture.
This recall affects Howmedica Osteonics Corp., healthcare facilities utilizing the Triathlon Hinge Femoral Prep Tray (Catalog Number 6543-6-514), and personnel responsible for sterile processing and surgical preparation.
Residual moisture following sterilization poses a risk to sterility maintenance and may indicate that the validated drying parameters are insufficient for the specific configuration of these trays when wrapped. Regulatory and QA teams should note that even small amounts of residual moisture can be viewed as a failure in reprocessing efficacy, potentially leading to increased scrutiny of sterilization validation data.
Review site-specific sterilization logs for affected trays to identify potential moisture issues. Update internal reprocessing protocols to ensure alignment with validated dry times, and monitor for any reports of compromised sterility or moisture-related issues at the point of use.
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: Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.. Firm: Howmedica Osteonics Corp. (Mahwah NJ United States). Status: Ongoing.
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