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
    48185
  • Event Risk Class
    Class 2
  • Event Number
    Z-2066-2008
  • Event Initiated Date
    2007-11-07
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71437
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • 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.

Device

Device Recall Allez Spine Laguna Pedicle Screw System
  • Model / Serial
    Catalog # LG-PR0650
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide to AZ, CA, CO & UT
  • Product Description
    Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650
  • Manufacturer
    Allez Spine, LLC

Manufacturer

Allez Spine, LLC
  • Manufacturer Address
    Allez Spine, LLC, 2301 Dupont Dr Ste 510, Irvine CA 92612-7518
  • Manufacturer Parent Company (2017)
    Allez Spine Llc
  • Source
    USFDA