IBS — Class II medical device recall Z-0397-2016
Terminated recall by In2Bones, SAS, reported 2015-12-16, distributed in TN. One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
| Recall number | Z-0397-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2Bones, SAS, Ecully, N/A, France |
| Recall initiated | 2015-11-18 |
| Classified | 2015-12-09 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-08-19 |
| Distributed | TN |
| Quantity | 20 units |
| Model numbers | ST014 |
Product
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Reason for recall
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0397-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.