BEUDAMED
    FDA Recall Terminated

    Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

    Recall: Z-0388-06 · Initiated October 21, 2005

    Recall

    Recall Number
    Z-0388-06
    Event Number
    34013
    Firm
    Ossur Grjothals 5 Reykjavik Ireland
    FEI Number
    3003764610
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 21, 2005
    Posted
    January 12, 2006
    Terminated
    March 20, 2007

    Description

    Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

    Reason

    After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.

    Action

    Telephone communication followed by notification letter mailed to end users (patients) and prosthetics workshops. A pre-paid package to return faulty components to Ossur included with mailed letters. New replacement feet will be shipped to customers.

    Distribution

    Nationwide

    Quantity

    48 (23 in US)