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In2Bones, SAS recalls In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Recalled March 31, 2021 · FDA recall Z-1283-2021 · 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. · FDA Class II
Units
60 units
Sold at
US Nationwide distribution in the state of TN.
Description
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.
Product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Manufacturer(s)
In2Bones, SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →