SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference
SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves mechanical interference preventing proper surgical use, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
SpineFrontier, Inc. is recalling 13 units of the Drill Guide - Chameleon FacetFuse Fixation System, Model 11-00028 Rev. A. These devices are used during the implantation of spinal intervertebral body fusion devices for skeletally mature patients. The affected units were distributed in the United States, including Puerto Rico, and the states of Colorado, Kansas, Massachusetts, and Texas.
The recall was initiated because the drill guides presented noticeable degrees of denting and/or bending prior to use in surgery. This physical deformation caused mechanical interference, which prevented drills and taps from being directed down the guides during the procedure. The drill guides are designed to provide a concentric pathway for surgical instruments while protecting soft tissue and measuring depth.
Healthcare providers who have these specific drill guides should stop using them immediately. The affected units are identified by lot codes 2520301 and 2520307. SpineFrontier, Inc. is the recalling firm responsible for managing the recall.
The recalled product
- 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
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 2520301
- 2520307
Distribution
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