BEUDAMED
    FDA Enforcement Class II Terminated

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    Recall: Z-0791-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0791-2013
    Event ID
    64160
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 13, 2013
    Initiation Date
    December 17, 2012
    Classification Date
    February 6, 2013
    Termination Date
    February 7, 2013
    Address
    4725 Calle Quetzal Ste B, N/A, Camarillo, CA, 93012-8429, United States

    Description

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    Reason

    The tip of the Quadra Trial Broach size 0, broke during a surgery.

    Code Info

    Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455

    Distribution

    US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands

    Quantity

    26 pieces U.S.A. (226 pieces Worldwide)