Events

Recall of Device Recall ILLICO access retractor

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
    51734
  • Event Risk Class
    Class 2
  • Event Number
    Z-0498-2010
  • Event Initiated Date
    2009-01-28
  • Event Date Posted
    2009-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81140
  • 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
    Retractor - Product Code GAD
  • Reason
    The recall was initiated after alphatec spine received a complaint on the illico posterior thoracolumbar access retractor. it was reported that one of the retractor arms in the retractor broke during surgery.
  • Action
    On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.

Device

Device Recall ILLICO access retractor
  • Model / Serial
    Lot number: 5271901
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AZ, CA, OR, TX, and Tokyo, Japan.
  • Product Description
    ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 || The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Manufacturer Parent Company (2017)
    Alphatec Spine Inc
  • Source
    USFDA