FDA-Device2021-11-24Class II
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.
Laboratoires Bodycad, Inc.
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.
Sold states
Distribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution.
Affected count
10 in the U.S.
Manufactured in
2035 Du Haut-Bord St, N/A, Quebec, N/A, Canada
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0244-2022Don't want to check this manually?
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