4 — Class II medical device recall Z-0958-2022
Completed recall by Acumed LLC, reported 2022-04-27, distributed nationwide. Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicat
| Recall number | Z-0958-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumed LLC, Hillsboro, OR, United States |
| Recall initiated | 2022-03-09 |
| Classified | 2022-04-20 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 537 units |
| Reason classes | potency, device malfunction |
| UPC / GTIN / UDI-DI | 10806378022869 |
| Model numbers | 3005-40010 |
Product
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Reason for recall
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
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-0958-2022. 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.