BEUDAMED
    FDA Recall 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 · Initiated October 21, 2014

    Recall

    Recall Number
    Z-0225-2015
    Event Number
    69693
    Firm
    Medacta Usa
    FEI Number
    3015500078
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 21, 2014
    Posted
    November 18, 2014
    Terminated
    March 14, 2016
    Address
    1556 W Carroll Ave, Chicago, IL, 60607-1012

    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.

    Action

    Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided. Customers with questions can contact Medacta USA at 805-910-6511.

    Distribution

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

    Quantity

    32 oblique handles