FDAJuly 2, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
laboratoires bodycadlaboratoires
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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