BEUDAMED
    FDA Recall Terminated

    Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

    Recall: Z-1131-2014 · Initiated January 28, 2014

    Recall

    Recall Number
    Z-1131-2014
    Event Number
    67435
    Firm
    AlterG, Incorporated
    FEI Number
    3008089345
    Product Code
    IOL
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 28, 2014
    Posted
    March 4, 2014
    Terminated
    May 13, 2014
    Address
    48438 Milmont Dr, Fremont, CA, 94538-7326

    Description

    Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

    Reason

    Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.

    Action

    The firm, AlterG, Inc, sent "Medical Device Recall Notification Anti-Gravity Short Exchange" letters dated February 6, 2014 to all customers beginning February 7, 2014 by Federal Express. The letter describes the product, problem and actions to be taken. The customers were instructed to review your inventory of shorts to identify any that are labeled ZIN1212 or ZIN0413 and return any shorts with these labeled production date using the return label provided. If you have any questions about this shorts exchange program or if there are any other ways we can be of assistance to you, please email us at [email protected] or call the support team at any time at 510-2705369.

    Distribution

    Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.

    Quantity

    2221 devices