Recall Z-1283-2021— In2Bones, SAS
Class II · Terminated
Class II FDA medical device recall by In2Bones, SAS, initiated 2021-02-09, terminated 2024-07-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- In2Bones, SAS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-09
- Terminated
- 2024-07-11
- Firm location
- Ecully, N/A, France
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.