Z-1871-2013Class II

Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were...

Name: Z-1871-2013 Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were...
Creator: SpineFrontier, Inc.
Published: 2012-11-09
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-11-09 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills... on 2012-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1871-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Posted: 2013-08-02
Terminated: 2015-06-05
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
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.
Product code: FZX Guide, Surgical, Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 13 drill guides
Distribution: US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
Product codes and lots: 2520301, 2520307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1871-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1871-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-02

Product code FZX

K071420UnclassifiedChameleon Fixation SystemSpinefrontier, Inc. / cleared 2008-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)