medical Class II Updated 2021-03-31

In2Bones, SAS recalls In2Bones Shannon Percutaneous Burr - Product Usage: indicat

Recalled Product

In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
View official government recall

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