Events

Recall of Device Recall IILICO MIS Posterior Spinal Fixation System

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

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
    55155
  • Event Risk Class
    Class 2
  • Event Number
    Z-0967-2013
  • Event Initiated Date
    2011-07-06
  • Event Date Posted
    2013-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90188
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    The rods were incorrectly laser etched as illico¿ straight cp tl rods, 110mm, when they were in fact manufactured to 100mm in length.
  • Action
    Alphatec Spine sent an Urgent Medical Device Recall letter dated July 6, 2011, to all affected customers. This notification described the product, problem and actions to be taken. The consignees were instructed to review their inventory to verify the affected device; abstain from use; immediately contact Alphatec Spine Sales Administration (salesadministration@alphatecspine.com) for instructions on how to return this affected product; and complete, sign and return confirmation form to Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad, CA 92008. If you have any questions, call 760-431-9286.

Device

Device Recall IILICO MIS Posterior Spinal Fixation System
  • Model / Serial
    Lot # 635436; Part #73601-110
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
  • Product Description
    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA