BEUDAMED
    FDA Recall Terminated

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    Recall: Z-1395-2017 · Initiated October 25, 2016

    Recall

    Recall Number
    Z-1395-2017
    Event Number
    76503
    Firm
    MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria
    FEI Number
    3000249315
    Product Code
    ISM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2016
    Posted
    March 2, 2017
    Terminated
    April 4, 2017

    Description

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    Reason

    Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

    Action

    MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

    Quantity

    538 units