FDAFDA recall Z-0164-2027 · Oct 21, 2026
Howmedica Osteonics Corp.: TS Universal Baseplate Finishing Tray recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
- 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.
- Recalling firm
- Howmedica Osteonics Corp., Mahwah, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-16
Source: openFDA enforcement record Z-0164-2027 · search recall number Z-0164-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.