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
    49444
  • Event Risk Class
    Class 2
  • Event Number
    Z-0153-2009
  • Event Initiated Date
    2008-08-21
  • Event Date Posted
    2008-10-28
  • 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=73335
  • 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
    Spinal Pedicle Fixation - Product Code MNI
  • Reason
    This action is being taken voluntarily as a result of a warning letter issued to aliez spine llc by the food & drug administration. the company decided it could better address the fda's concerns regarding current good manufacturing practice requirements of the quality system without any product in the market so it could focus all of its efforts on responding to the fda.
  • Action
    Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.

Device

Device Recall Allez Spine Laguna Pedicle Screw System
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
  • Product Description
    Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 || Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; || IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 || Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; || DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 || Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; || DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; || DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 || Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 || DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex || Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
  • 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