Laboratoires Bodycad, Inc. recalls Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant…

Recall date

July 2, 2021

Source

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

Recall number

Z-0244-2022

FDA classification

Class II

Brand / firm

Laboratoires Bodycad, Inc.

Sold / distributed

Distribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution.

Why it was recalled

There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this 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

Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.