Class II — Osteomed, LLC
| Recalling firm | OSTEOMED |
|---|---|
| Registered facility | OSTEOMED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| Product | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile |
| Quantity | N/A |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG. |
| Initiated | 2023-05-31 |
| Classified | 2023-07-07 |
| Recall number | Z-2108-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Osteomed, LLC (Z-2108-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92479/
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