Recall Z-0164-2027— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2026-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.. 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..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-16
- Firm location
- Mahwah, NJ, United States
Product description
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.