BEUDAMED
    FDA Enforcement Class II 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 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1699-2014
    Event ID
    68080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cochlear Americas Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    April 9, 2014
    Classification Date
    June 2, 2014
    Termination Date
    October 6, 2014
    Address
    13059 E Peakview Ave, Centennial, CO, 80111-6511, United States

    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.

    Code Info

    Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008

    Distribution

    Nationwide Distribution.

    Quantity

    288