Howmedica Osteonics Corp. recalls TS Misc. Instruments Tray
- Recalling company
- Howmedica Osteonics Corp.
- Product
- TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 16, 2026
- Reported
- Oct 21, 2026
- 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.
- Status
- Ongoing
- Quantity
- 577 trays
- Lot / codes
- Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
- Company location
- Mahwah, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0167-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0167-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.