BEUDAMED
    FDA Recall Terminated

    Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.

    Recall: Z-0536-2011 · Initiated September 15, 2010

    Recall

    Recall Number
    Z-0536-2011
    Event Number
    57178
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 15, 2010
    Posted
    December 2, 2010
    Terminated
    July 27, 2011
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.

    Reason

    These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all devices have nonconforming geometry.

    Action

    The firm sent URGENT DEVICE CORRECTION AND REMOVAL notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by surgeons.

    Distribution

    US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.

    Quantity

    158 all sizes of 5764