Events

Recall of Fortex Pedicle Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by XTANT MEDICAL 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
    76842
  • Event Risk Class
    Class 2
  • Event Number
    Z-1884-2017
  • Event Initiated Date
    2017-04-12
  • Event Date Posted
    2017-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154382
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Reason
    The material type on the label may incorrectly state ti6al-4v eli. the rods are composed of cobalt chromium.
  • Action
    XTANT sent an Urgent Medical Device Removal letter dated 4/12/2017 to customers with a Return Response Acknowledgement and Receipt form. The letter identified the affected product, problem and actions to be taken. For questions call 406-570-7028.

Device

Fortex Pedicle Screw System
  • Model / Serial
    Part number X077-0420, lot number 041218
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
  • Product Description
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. || Product Usage: || The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
  • Manufacturer
    XTANT MEDICAL INC

Manufacturer

XTANT MEDICAL INC
  • Manufacturer Address
    XTANT MEDICAL INC, 664 Cruiser Ln, Belgrade MT 59714-9719
  • Manufacturer Parent Company (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA