Recall Z-1871-2013— SpineFrontier, Inc.

Name: FDA recall Z-1871-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-09

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2012-11-09, terminated 2015-06-05. It names one FDA 510(k) clearance: K071420. Product: 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.. 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..

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Terminated: 2015-06-05
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071420 — CHAMELEON FIXATION SYSTEMSpinefrontier, Inc.·cleared 2008-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.