Device product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Z-1283-2021
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 87341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-1283-2021
Official wording
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.
Code information: Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
Distribution pattern: US Nationwide distribution in the state of TN.
Derived failure modes
-
Unknown
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.