Class II — In2Bones, SAS
| Recalling firm | In2Bones SAS |
|---|---|
| Registered facility | In2Bones SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. |
| Product | IBS - Osteosynthesis screws for bone fixation Model S25 ST014. |
| Quantity | 20 units |
| Distribution | US Distribution to the state of :TN |
| Initiated | 2015-11-18 |
| Classified | 2015-12-09 |
| Terminated | 2016-08-19 |
| Recall number | Z-0397-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2Bones, SAS (Z-0397-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72711/
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