BEUDAMED
    FDA Enforcement Class II Terminated

    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

    Recall: Z-0225-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0225-2015
    Event ID
    69693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 26, 2014
    Initiation Date
    October 21, 2014
    Classification Date
    November 18, 2014
    Termination Date
    March 14, 2016
    Address
    1556 W Carroll Ave, N/A, Chicago, IL, 60607-1012, United States

    Description

    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

    Reason

    The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

    Code Info

    Model Number: 03.22.10.0262; Lot Number: 1314256

    Distribution

    Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.

    Quantity

    32 oblique handles