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 of the thread on the screw head. |
| Product | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW® Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius |
| Quantity | 19 units |
| Distribution | Worldwide Distribution - US TN only and Internationally to France and Switzerland |
| Initiated | 2016-12-19 |
| Classified | 2017-01-06 |
| Terminated | 2017-02-01 |
| Recall number | Z-0952-2017 |
| 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-0952-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76104/
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