TS Universal Baseplate Finishing Tray recall (Howmedica Osteonics Corp.)
Medical deviceClass IIOngoing
Summary: Howmedica Osteonics Corp. is recalling 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.
What is being recalled
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0164-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 16, 2026 |
| Reported | October 21, 2026 |
| Company | Howmedica Osteonics Corp. |
| Company location | Mahwah, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 605 trays |
More recalls from Howmedica Osteonics Corp. · all medical device recalls · recalls from September 2026