Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1871-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1871-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Spinefrontier, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1871-2013.
SpineFrontier, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Spinefrontier, Inc. Recall FAQ
Spinefrontier, Inc. is the subject of a medical implants safety report: Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric.... The notice was published on November 9, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 13 units are potentially affected.