Recall Z-1283-2021 ยท GFF Bur, Surgical, General & Plastic Surgery
In2Bones, SAS
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
| Date | Feb 9, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers. |
| Quantity | 60 units |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.