BEUDAMED
    FDA Recall Terminated

    Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ

    Recall: Z-1750-2008 · Initiated May 17, 2007

    Recall

    Recall Number
    Z-1750-2008
    Event Number
    47764
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 17, 2007
    Posted
    August 17, 2008
    Terminated
    August 19, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ

    Reason

    The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.

    Action

    Styrker Branches/Agencies were notified of the incorrect information printed in the protocal on May 17, 2007 via an Important Product Correction letter. The letter requested that all incorrect copies of the protocol be located and destroyed immediately. They requested that the Acknowledgement Form be completed and faxed, and that a Stryker Orthopaedics Customer Service rep be contacted in order to reorder the destroyed product.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.

    Quantity

    2501 units