In2Bones Shannon Percutaneous Burr — Class II medical device recall Z-1283-2021
Terminated recall by In2Bones, SAS, reported 2021-03-31, distributed nationwide. This Field Action is being conducted following identification of manufacturing non-conformity of some batches
| Recall number | Z-1283-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2Bones, SAS, Ecully, N/A, France |
| Recall initiated | 2021-02-09 |
| Classified | 2021-03-19 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2024-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 60 units |
| Reason classes | device malfunction |
| Lot numbers | 2001089, 2007087, 2009139, 2011062 |
| Model numbers | 01511, 01512, G01 |
Product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Reason for recall
This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
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-1283-2021. 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.