Drill Guide — Class II medical device recall Z-1871-2013
Terminated recall by SpineFrontier, Inc., reported 2013-08-14, distributed in CO, KS, MA, PR, TX. Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a r
| Recall number | Z-1871-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2012-11-09 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-06-05 |
| Distributed | CO, KS, MA, PR, TX |
| Quantity | 13 drill |
| Model numbers | 11-00028 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1871-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.