FDA recall Z-0244-2022

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.

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

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

Key facts

Status

Terminated

Initiation date

2021-07-02

Report date

2021-11-24

Termination date

2023-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Quebec, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0244-2022