FDA Device recall Z-0958-2022
4.0mm x 10mm Cannulated Screw, Short Thread
- FDA Device
- Class II
- completed
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of 4.0mm x 10mm Cannulated Screw, Short Thread by Acumed, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-03-09 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acumed |
| Distribution | US |
Product
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Reason
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.
Identifiers
| code_info | All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2022%22
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