FDA Device recall Z-2108-2023
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
- FDA Device
- Class II
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile by Osteomed, citing screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2108-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-31 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Osteomed |
| Distribution | US |
Product
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Reason
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Identifiers
| code_info | Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2108-2023%22
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