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.
Other recalls by Osteomed
- REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
FDA Device · Class II · 2023-07-19 · Osteomed - OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01…
FDA Device · Class II · 2021-12-15 · Osteomed - OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed - OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced b…
FDA Device · Class II · 2020-06-10 · Osteomed - OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2108-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.