BEUDAMED
    FDA Recall Terminated

    One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

    Recall: Z-0807-04 · Initiated March 1, 2004

    Recall

    Recall Number
    Z-0807-04
    Event Number
    28505
    Firm
    Spinal Concepts, Inc
    FEI Number
    3000718496
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2004
    Posted
    July 20, 2004
    Terminated
    April 13, 2007
    Address
    5301 Riata Park Ct, Bldg F, Austin, TX, 78727-3436

    Description

    One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

    Reason

    Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.

    Action

    The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.

    Distribution

    Nationwide

    Quantity

    15 (1706-1024); 14 (1706-1026); 17 (1706-1028); 8 (1706-1030); 8 (1706-1032); and 25 (1757-1)