BEUDAMED
    FDA Recall Terminated

    Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

    Recall: Z-0003-2012 · Initiated September 16, 2011

    Recall

    Recall Number
    Z-0003-2012
    Event Number
    59979
    Firm
    Cochlear Americas Inc.
    FEI Number
    3005900820
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 16, 2011
    Posted
    October 3, 2011
    Terminated
    July 10, 2012
    Address
    13059 E Peakview Ave, Englewood, CO, 80111-6511

    Description

    Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

    Reason

    Cochlear implant may shut down and cease to function.

    Action

    Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.

    Quantity

    33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.