medical Class II Updated 2021-11-24

Laboratoires Bodycad, Inc. recalls Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, r

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: CO, MI, NY
Lot/Code Info: Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.
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