BEUDAMED
    FDA Recall Terminated

    Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.

    Recall: Z-0371-2010 · Initiated May 5, 2009

    Recall

    Recall Number
    Z-0371-2010
    Event Number
    53772
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 5, 2009
    Posted
    November 20, 2009
    Terminated
    November 20, 2009
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.

    Reason

    incorrect size markings on component

    Action

    The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.

    Distribution

    Nationwide

    Quantity

    20 units