FDA Medical Device · Z-0164-2027

TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.

Class II · Ongoing

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.

Affected lots / codes — check yours against thisCatalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.

Recalling firm: Howmedica Osteonics Corp., Mahwah, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 605 trays
Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
Recall initiated: September 16, 2026
Classified: October 15, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0164-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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