BEUDAMED
    FDA Enforcement Class II Terminated

    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

    Recall: Z-0267-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0267-2013
    Event ID
    53337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    October 13, 2008
    Classification Date
    November 8, 2012
    Termination Date
    November 9, 2012
    Address
    4725 Calle Quetzal Unit B, N/A, Camarillo, CA, 93012-9101, United States

    Description

    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

    Reason

    Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.

    Code Info

    Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)

    Distribution

    Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.

    Quantity

    12 units