BEUDAMED
    FDA Recall Terminated

    Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.

    Recall: Z-2711-2011 · Initiated April 27, 2011

    Recall

    Recall Number
    Z-2711-2011
    Event Number
    58809
    Firm
    Heinz Kurz GmbH Medizintechnik Tuebinger Strasse 3 Dillingen Germany
    FEI Number
    6062
    Product Code
    ETA
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 27, 2011
    Posted
    June 30, 2011
    Terminated
    November 23, 2011

    Description

    Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.

    Reason

    Outer package labels product .75 mm longer than actual size.

    Action

    Kurz Medical, Inc. sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.

    Distribution

    Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.

    Quantity

    32, only 8 consigned with U. S. hospitals