Events

Recall of Device Recall Allez Spine Laguna Pedicle Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allez Spine, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44911
  • Event Risk Class
    Class 2
  • Event Number
    Z-0191-2008
  • Event Initiated Date
    2007-07-30
  • Event Date Posted
    2008-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64524
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pedicle Screw System - Product Code MNI
  • 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.

Device

Device Recall Allez Spine Laguna Pedicle Screw System
  • Model / Serial
    Lot Number: 10528
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT
  • Product Description
    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
  • Manufacturer
    Allez Spine, LLC

Manufacturer

Allez Spine, LLC
  • Manufacturer Address
    Allez Spine, LLC, 2301 Dupont Drive, Suite 510, Irvine CA 92612
  • Manufacturer Parent Company (2017)
    Allez Spine Llc
  • Source
    USFDA