BEUDAMED
    FDA Recall Terminated

    Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX

    Recall: Z-1038-04 · Initiated March 8, 2004

    Recall

    Recall Number
    Z-1038-04
    Event Number
    28508
    Firm
    Spinal Concepts, Inc
    FEI Number
    3000718496
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 8, 2004
    Posted
    July 20, 2004
    Terminated
    April 13, 2007
    Address
    5301 Riata Park Ct, Bldg F, Austin, TX, 78727-3436

    Description

    Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX

    Reason

    Recall of product literature that describes use of the device.

    Action

    A product caution letter was faxed to each distributor beginning March 9. The fax was followed by a Federal Express delivery of the document beginning March 9.

    Distribution

    Tennessee, Michigan, Washington, Kentucky, California, Colorado, Ohio, Oregon, Kansas, Texas, New York, Virginia, Florida, Virginia, New Mexico, Minnesota, Louisiana, Wisconsin, Oklahoma, Pennsylvania, North Carolina, Maryland, Arizona, Utah, Missouri, South Dakota, Illinois, and New Jersey

    Quantity

    Unknown. The amount of literature actually distributed to the field is not controlled. Distributors are able to make copies of documents.