BEUDAMED
    FDA Recall Terminated

    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

    Recall: Z-1699-2014 · Initiated April 9, 2014

    Recall

    Recall Number
    Z-1699-2014
    Event Number
    68080
    Firm
    Cochlear Americas Inc.
    FEI Number
    3005900820
    Product Code
    LXB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 9, 2014
    Posted
    June 2, 2014
    Terminated
    October 6, 2014
    Address
    13059 E Peakview Ave, Centennial, CO, 80111-6511

    Description

    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

    Reason

    Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.

    Action

    Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.

    Distribution

    Nationwide Distribution.

    Quantity

    288