Events

Recall of Device Recall Zodiac Polyaxial 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
    50685
  • Event Risk Class
    Class 2
  • Event Number
    Z-0491-2010
  • Event Initiated Date
    2008-11-03
  • Event Date Posted
    2009-12-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75994
  • 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
    Alphatec spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. as a result, they are conducting a voluntary recall of the zodiac titanium cannulated polyaxial screw 6.5 mm x 50 mm l.
  • Action
    Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.

Device

Device Recall Zodiac Polyaxial Spinal Fixation System
  • Model / Serial
    Part Number: 62665-50 Lot Number: 617945
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, CA, FL, TX
  • Product Description
    Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
  • 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