BEUDAMED
    FDA Recall Terminated

    Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.

    Recall: Z-0119-2010 · Initiated September 30, 2009

    Recall

    Recall Number
    Z-0119-2010
    Event Number
    53492
    Firm
    Cochlear Americas Inc.
    FEI Number
    3005900820
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 30, 2009
    Posted
    November 2, 2009
    Terminated
    December 22, 2009
    Address
    13059 E Peakview Ave, Englewood, CO, 80111-6511

    Description

    Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.

    Reason

    Cochlear implant device component was mis-labeled.

    Action

    On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.

    Distribution

    Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.

    Quantity

    10 units