Reported Mar 31, 2021 · Terminated
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
In2Bones, SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: In2Bones, SAS · 28 Chemin du petit Bois · Ecully, N/A · N/A
Is this the product you have?
- In2Bones Shannon
- Percutaneous Burr - Product Usageindicated for forefoot mini-invasive and percutaneous surgery
- Lot codes and dates
Model G01 01511Batches 2009139 and 2001089 Model G01 01512Batches 2007087 and 2011062
- Amount recalled
- 60 units
Where it was sold
- Nationwide
- TN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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