BEUDAMED
    FDA Recall Terminated

    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems.

    Recall: Z-0296-06 · Initiated November 14, 2005

    Recall

    Recall Number
    Z-0296-06
    Event Number
    34015
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 14, 2005
    Posted
    December 17, 2005
    Terminated
    October 2, 2007
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems.

    Reason

    Modification to labeling for surgical implant.

    Action

    Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.

    Distribution

    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.

    Quantity

    Approximately 1253 SC-AcuFix ThinLine Surgical Techniques