FDA-Device2021-03-31Class II
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
In2Bones, SAS
Hazard
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.
Sold states
US Nationwide distribution in the state of TN.
Affected count
60 units
Manufactured in
28 Chemin du petit Bois, N/A, Ecully, N/A, France
Products
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2021Don't want to check this manually?
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