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

Recall date

February 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1283-2021

FDA classification

Class II

Brand / firm

In2Bones, SAS

Sold / distributed

US Nationwide distribution in the state of 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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