BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1259-2020 · Initiated March 18, 2019

    Recall

    Recall Number
    Z-1259-2020
    Event Number
    84617
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 18, 2019
    Posted
    February 18, 2020
    Terminated
    April 27, 2021
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    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.

    Action

    On March 18, 2019, the firm sent a "Voluntary Field Action" letter was sent to Japanese surgeons who implanted the device. The firm has stopped sales until the documentation is finalized. The field action letter informed customers that the action was due to an error in documentation and poses no risk to patient safety. The serial numbers of implanted HiRes90K Advantage cochlear implants with 1J and MS electrodes will be made available on the PMDA website.

    Distribution

    No US distribution OUS: Japan

    Quantity

    4