BEUDAMED
    FDA Enforcement Class II Terminated

    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.

    Recall: Z-1097-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1097-2014
    Event ID
    67250
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur Americas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 5, 2014
    Initiation Date
    October 15, 2012
    Classification Date
    February 26, 2014
    Termination Date
    February 28, 2014
    Address
    19762 Pauling, Foothill Ranch, CA, 92610-2611, United States

    Description

    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.

    Reason

    OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.

    Code Info

    Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322

    Distribution

    US Nationwide distribution.

    Quantity

    144 units