Class II — In2Bones, SAS
| Recalling firm | In2Bones SAS |
|---|---|
| Registered facility | In2Bones SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. |
| Product | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. |
| Quantity | 15 units |
| Distribution | Distributed in the state of TN. |
| Initiated | 2015-03-09 |
| Classified | 2015-03-25 |
| Terminated | 2016-05-19 |
| Recall number | Z-1319-2015 |
| 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-1319-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70736/
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