Events

Recall of Device Recall Allez Spine Cross Connectors

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-0155-2009
  • 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=73337
  • 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 NKB
  • 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 Cross Connectors
  • 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 Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 || Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm
  • 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