REF 218-1604-SP-10 — Class II medical device recall Z-2108-2023
Ongoing recall by Osteomed, LLC, reported 2023-07-19, distributed nationwide. Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate h
| Recall number | Z-2108-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osteomed, LLC, Addison, TX, United States |
| Recall initiated | 2023-05-31 |
| Classified | 2023-07-07 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00845694066006 |
| Lot numbers | 1177274, 1177331, 1177823 |
| Model numbers | 218-1604-SP-10 |
Product
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Reason for recall
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2108-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.