FDA Device recall Z-1283-2021
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery by In2bones Sas, citing 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 bre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1283-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-09 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | In2bones Sas |
| Distribution | US |
Product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Reason
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.
Identifiers
| code_info | Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1283-2021%22
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