BEUDAMED
    FDA Recall Terminated

    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA

    Recall: Z-0188-2008 · Initiated July 30, 2007

    Recall

    Recall Number
    Z-0188-2008
    Event Number
    44911
    Firm
    Allez Spine, LLC
    FEI Number
    3005032381
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 30, 2007
    Posted
    March 11, 2008
    Terminated
    April 9, 2012
    Address
    2301 Dupont Drive, Suite 510, Irvine, CA, 92612

    Description

    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA

    Reason

    Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.

    Action

    On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.

    Distribution

    Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT

    Quantity

    325