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.
This recall has been terminated (originally issued August 2, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- November 9, 2012
- Posted
- August 2, 2013
- Terminated
- June 5, 2015
- Recall Number
- Z-1871-2013
- Quantity
- 13 drill guides
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
Lot / Code Info
2520301, 2520307
Root Cause
Device Design
Action Taken
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.