I — Class II medical device recall Z-1319-2024
Ongoing recall by In2Bones, SAS, reported 2024-03-27, distributed nationwide. This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression
| Recall number | Z-1319-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2Bones, SAS, Ecully, France |
| Recall initiated | 2024-01-26 |
| Classified | 2024-03-20 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 59 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03760225710685 |
| Lot numbers | 2306007, 31/MAY/2028 |
| Model numbers | S65, ST175 |
Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Reason for recall
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.
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-1319-2024. 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.