Device Recall Drill Guide (guide, surgical, instrument)

  • Model / Serial
    2520301, 2520307
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • 1 Event

Manufacturer

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