FDA Device recall Z-0957-2026
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener by Smith And Nephew, citing removal of affected lot of screws due to labeling error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0957-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-24 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason
Removal of affected lot of screws due to labeling error.
Identifiers
| code_info | Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2026%22
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