BEUDAMED
    FDA Recall Terminated

    Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR0750

    Recall: Z-2067-2008 · Initiated November 7, 2007

    Recall

    Recall Number
    Z-2067-2008
    Event Number
    48185
    Firm
    Allez Spine, LLC
    FEI Number
    3005032381
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2007
    Posted
    September 17, 2008
    Terminated
    January 19, 2010
    Address
    2301 Dupont Dr, Ste 510, Irvine, CA, 92612-7518

    Description

    Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR0750

    Reason

    This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.

    Action

    Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory. All customers and consignees were contacted by the firm.

    Distribution

    Nationwide to AZ, CA, CO & UT

    Quantity

    10