BEUDAMED
    FDA Recall Terminated

    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.

    Recall: Z-0451-05 · Initiated January 4, 2005

    Recall

    Recall Number
    Z-0451-05
    Event Number
    30854
    Firm
    Warsaw Orthopedic, Inc.
    FEI Number
    1824199
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 4, 2005
    Posted
    January 28, 2005
    Terminated
    June 30, 2005
    Address
    2500 Silveus Xing, Warsaw, IN, 46582-8598

    Description

    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.

    Reason

    The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.

    Action

    Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.

    Distribution

    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.

    Quantity

    182