BEUDAMED
    FDA Recall Terminated

    Allocraft TLIF Bone Inserter.

    Recall: Z-0011-06 · Initiated April 4, 2005

    Recall

    Recall Number
    Z-0011-06
    Event Number
    31984
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2005
    Posted
    October 7, 2005
    Terminated
    August 15, 2007
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Allocraft TLIF Bone Inserter.

    Reason

    Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.

    Action

    The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required.

    Distribution

    The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.

    Quantity

    9