Recall of Device Recall Drill Guide (guide, surgical, instrument)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SpineFrontier, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Guide surgical instrument - Product Code FZX
  • Reason
    Prior to use in surgery, the drill guides were presenting noticeable degrees of denting and/or bending. as a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
  • Action
    Spine Frontier sent an Advisory Notice dated November 9, 2012, via email to all affected customers. Customers were advised that their FacetFuse Drill Guides need to be replaced. Customers were instructed to write their number ( included in the email) on the outside of the package and provide us with the tracking information. A replacement part has been sent out to you. If you have any further questions please call (978) 232-3990.


  • Model / Serial
    2520301, 2520307
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
  • Product Description
    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A || FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
  • Manufacturer


  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
  • Source