Recall Z-1871-2013
SpineFrontier, Inc. · initiated November 9, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 2520301, 2520307
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.
FDA-determined 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.
Details
- Recall number
- Z-1871-2013
- Initiated
- November 9, 2012
- Posted by FDA
- August 2, 2013
- Terminated
- June 5, 2015
- Product code
- FZX – Guide, Surgical, Instrument
- Quantity
- 13 drill guides
- Distribution
- US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA