Drill Guide - Chameleon FacetFuse Fixation System recall
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the…
Why was Drill Guide - Chameleon FacetFuse Fixation System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2520301, 2520307
- Product
- Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the…
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 13 drill guides
- Distribution
- US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
- Recall date
- August 14, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)