Class II — Howmedica Osteonics Corp.
| Recalling firm | Howmedica Osteonics Corp. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. |
| Quantity | 577 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. |
| Initiated | 2026-09-16 |
| Classified | 2026-10-15 |
| Recall number | Z-0167-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Howmedica Osteonics Corp. (Z-0167-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99883/
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