Class II — In2Bones, SAS
| Recalling firm | In2Bones SAS |
|---|---|
| Registered facility | In2Bones SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels. |
| Product | I.B.S® 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 |
| Quantity | 63 units |
| Distribution | US Nationwide distribution in the state of Tennessee. |
| Initiated | 2024-01-26 |
| Classified | 2024-03-20 |
| Recall number | Z-1320-2024 |
| 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-1320-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94063/
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