Home / Recalls / Laboratoires Bodycad, Inc. / Z-0244-2022

Z-0244-2022 Class II Terminated

Recalled by Laboratoires Bodycad, Inc. — Quebec, N/A

Recall Details

Product Type: Devices
Report Date: November 24, 2021
Initiation Date: July 2, 2021
Termination Date: January 4, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 in the U.S.

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.