FDA Device recall Z-0397-2016
IBS - Osteosynthesis screws for bone fixation Model S25 ST014
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of IBS - Osteosynthesis screws for bone fixation Model S25 ST014 by In2bones Sas, citing one batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0397-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-18 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | In2bones Sas |
| Distribution | TN |
Product
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Reason
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Identifiers
| code_info | 1509058 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0397-2016%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.