In2Bones, SAS Recall 87341
Description: In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
In2Bones, SAS Recall 87341 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1283-2021 |
| Event ID | 87341 |
| Event Description | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of TN. |
| Quantity | 60 units |
| Recall 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. |
| Device Classification | 20210331 |
| Device Code Info | Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062 |
| Center Classification Date | 20210319 |
| Recall Initiation Date | 20210209 |
| Recalling Firm | In2Bones, SAS |
| Initial Notification | |
| Similar To |