Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Drill Guide - Chameleon FacetFuse Fixation System Recalled by SpineFrontier, Inc. Due to Prior to use in surgery, the Drill Guides...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SpineFrontier, Inc. directly.
Affected Products
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.
Quantity: 13 drill guides
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CO, KS, MA, TX
About SpineFrontier, Inc.
SpineFrontier, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report