BEUDAMED
    FDA Recall Terminated

    RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

    Recall: Z-1825-2014 · Initiated June 2, 2014

    Recall

    Recall Number
    Z-1825-2014
    Event Number
    68535
    Firm
    Ability Dynamics LLC
    FEI Number
    3008584163
    Product Code
    ISW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 2, 2014
    Posted
    June 18, 2014
    Terminated
    September 22, 2014
    Address
    2082 E University Dr, Tempe, AZ, 85281-4632

    Description

    RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

    Reason

    Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.

    Action

    Ability Dynamics sent an Urgent Medical Device Correction Notice letter dated June 2, 2014 to all affected customers (Prosthetist) who purchased the RUSH Prosthetic Foot. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Bracket Bolt Replacement Form and return to Ability Dynamics. Customers with questions are instructed to contact Rich Sainz, National Clinical Manager, 2082 E. University Dr. Tempe AZ 85281 (480) 717-1412, [email protected].

    Distribution

    Worldwide Distribution - US (nationwide) and in the countries of Australia and Canada.

    Quantity

    175 units