Drug recall
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed…
FDA recall event 64985 · Class II · SpineFrontier, Inc.
Key facts
| Event ID | 64985 |
|---|---|
| Recall numbers | Z-1871-2013 |
| Recalling firm | SpineFrontier, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 9, 2012 |
| Report date | Aug 14, 2013 |
| Termination date | Jun 5, 2015 |
| City | Beverly |
| State | MA |
| Country | United States |
| FEI number | 3005977257 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: