BEUDAMED
    FDA Recall Terminated

    Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

    Recall: Z-0620-2008 · Initiated October 19, 2007

    Recall

    Recall Number
    Z-0620-2008
    Event Number
    45479
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 19, 2007
    Posted
    March 19, 2008
    Terminated
    May 21, 2008
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

    Reason

    Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

    Action

    Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.

    Distribution

    Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.

    Quantity

    31