BEUDAMED
    FDA Recall Terminated

    C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm

    Recall: Z-0211-04 · Initiated November 7, 2003

    Recall

    Recall Number
    Z-0211-04
    Event Number
    27724
    Firm
    Interpore Cross International Inc
    FEI Number
    1000160576
    Product Code
    DKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2003
    Posted
    December 11, 2003
    Terminated
    April 20, 2004
    Address
    181 Technology Dr, Irvine, CA, 92618-2402

    Description

    C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm

    Reason

    Step drills from Lot 25947 may have been mis-etched.

    Action

    The consignees will be notified by letter.

    Distribution

    U.S., Netherlands, Australia, Venezuela, Mexico, Columbia and Brazil

    Quantity

    433 units