BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0244-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0244-2022
    Event ID
    88878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laboratoires Bodycad, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    July 2, 2021
    Classification Date
    November 17, 2021
    Termination Date
    January 4, 2023
    Address
    2035 Du Haut-Bord St, N/A, Quebec, N/A, N/A, Canada

    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

    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.

    Code Info

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

    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.

    Quantity

    10 in the U.S.