BEUDAMED
    FDA Enforcement Class II Terminated

    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger

    Recall: Z-0467-2013 · Reported December 12, 2012

    Enforcement

    Recall Number
    Z-0467-2013
    Event ID
    63646
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    iwalk inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2012
    Initiation Date
    October 26, 2012
    Classification Date
    December 4, 2012
    Termination Date
    September 26, 2014
    Address
    4 Crosby Dr, N/A, Bedford, MA, 01730-1402, United States

    Description

    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger

    Reason

    Battery may over-heat during charging and smoke

    Code Info

    Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973

    Distribution

    Nationwide Distribution including OH, NC, and NY.

    Quantity

    21 Batteries; 9 Chargers