BEUDAMED
    FDA Enforcement Class II Terminated

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    Recall: Z-2080-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2080-2013
    Event ID
    65800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Corp. Hq.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 16, 2013
    Classification Date
    August 27, 2013
    Termination Date
    June 4, 2014
    Address
    Barkausenweg 10, Hamburg, N/A, Germany

    Description

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    Reason

    The trial stems were manufactured using the wrong design.

    Code Info

    Lots: B206025, B048090, B101172

    Distribution

    US Distribution to the state of Tennessee only.

    Quantity

    8 units