BEUDAMED
    FDA Enforcement Class III Terminated

    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

    Recall: Z-1259-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1259-2020
    Event ID
    84617
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Bionics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    March 18, 2019
    Classification Date
    February 18, 2020
    Termination Date
    April 27, 2021
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398, United States

    Description

    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

    Reason

    Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

    Code Info

    All Lots, UDI (01)07630016832185 Not distributed within the US

    Distribution

    No US distribution OUS: Japan

    Quantity

    4