Z-1871-2013 Class II Terminated
FDA device recall Z-1871-2013 was initiated by SpineFrontier, Inc. on Nov 9, 2012 and is designated Class II. 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… The recall status is terminated (terminated Jun 5, 2015). Affected quantity: 13 drill guides.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Nov 9, 2012
- Termination Date
- Jun 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 drill guides
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.
Distribution pattern
US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
Code information
2520301, 2520307
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1871-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026