SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1871-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 9, 2012

Date Posted: August 14, 2013

Recall Number: Z-1871-2013

Event ID: 64985

Reason for Recall:

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.

Status: Terminated

Product Quantity: 13 drill guides

Code Information:

2520301, 2520307

Distribution Pattern:

US Distribution including Puerto Rico and the states of CO, KS, MA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated