BEUDAMED
    FDA Recall Terminated

    StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317

    Recall: Z-0479-2008 · Initiated October 5, 2007

    Recall

    Recall Number
    Z-0479-2008
    Event Number
    45528
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2007
    Posted
    January 23, 2008
    Terminated
    January 23, 2008
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317

    Reason

    The screws may fracture

    Action

    The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.

    Distribution

    Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.

    Quantity

    48 units