BEUDAMED
    FDA Enforcement Class II Terminated

    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.

    Recall: Z-1322-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1322-2015
    Event ID
    70693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur H / F
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 1, 2015
    Initiation Date
    February 26, 2015
    Classification Date
    March 25, 2015
    Termination Date
    November 20, 2015
    Address
    Grjothals 5, Reykjavik, N/A, Iceland

    Description

    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.

    Reason

    The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.

    Code Info

    Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498

    Distribution

    Worldwide distribution: US distribution in TN and country of: Austria.

    Quantity

    4715 units (2 units affected)