BEUDAMED
    FDA Recall Terminated

    Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.

    Recall: Z-1617-2009 · Initiated May 29, 2009

    Recall

    Recall Number
    Z-1617-2009
    Event Number
    52169
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 29, 2009
    Posted
    July 27, 2009
    Terminated
    December 22, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.

    Reason

    The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

    Action

    Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.

    Distribution

    Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.

    Quantity

    147 of both products.