BEUDAMED
    FDA Recall Terminated

    Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    Recall: Z-0438-2008 · Initiated October 10, 2007

    Recall

    Recall Number
    Z-0438-2008
    Event Number
    45456
    Firm
    Aesculap Implant Systems
    FEI Number
    2916714
    Product Code
    LWJ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 10, 2007
    Posted
    December 11, 2007
    Terminated
    February 7, 2008
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    Reason

    Sterility (package integrity) Compromised: Device package damaged during shipment

    Action

    The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.

    Distribution

    Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.

    Quantity

    167 units