Recall Z-0164-2027 ยท FSM Tray, Surgical, Instrument
Howmedica Osteonics Corp.
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
| Date | Oct 15, 2026 (initiated Sep 16, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | Stryker notified consignees on about 09/16/2026 via "MEDICAL DEVICE CORRECTION" letter mailed through UPS 2-day air. Consignees were informed that reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes, however, these trays require a sterilization dry time of 40 minutes when sterilized in blue wrap. Consignees were instructed to inform users of the Medical Device Correction and forward the notice to all individuals who need to be made aware or organizations who have consigned product, review and follow the updated instructions provided in LSTPI-B Cleanin |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.