BEUDAMED
    FDA Recall Terminated

    Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.

    Recall: Z-2026-2009 · Initiated June 23, 2009

    Recall

    Recall Number
    Z-2026-2009
    Event Number
    52773
    Firm
    Ossur Engineering, Inc
    FEI Number
    3002440200
    Product Code
    ISP
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 23, 2009
    Posted
    September 4, 2009
    Terminated
    March 6, 2012
    Address
    910 Burstein Dr, Albion, MI, 49224-4011

    Description

    Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.

    Reason

    The plastic caps have come off or become loose when the user stepped into their prosthesis.

    Action

    Customers were sent a Safety Notice Voluntary Product Recall, dated June 23, 2009, that advised them to return any unused valves to Ossur for a free replacement. Those using valves in combination with a cushion liner and suspension sleeve should replace immediately if problems are experienced, otherwise replace at next routine service. Customers using valve in combination with an Iceross Seal-In liner should replace ASAP and return used valves to Ossur for free replacement. Customers with questions can call Darlyne Roa 1-800-233-6263 ext 1023743.

    Distribution

    Worldwide Distribution

    Quantity

    4,647