BEUDAMED
    FDA Recall Terminated

    Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55

    Recall: Z-0367-2012 · Initiated November 16, 2011

    Recall

    Recall Number
    Z-0367-2012
    Event Number
    60419
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 16, 2011
    Terminated
    August 28, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55

    Reason

    Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.

    Action

    On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement to Zimmer

    Distribution

    Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK

    Quantity

    1 unit (International Only Switzerland)