Blackstone Medical Modular Spinal Fixation System
On December 23, 2005, the U.S. Food and Drug Administration (FDA) officially recalled the Blackstone Medical Modular Spinal Fixation System with the full consent of its manufacturer. The Blackstone Medical Modular Spinal Fixation System had been used to render certain spinal areas immobile and stable during and after hundreds of patient spine surgeries.
Marketed by Blackstone Medical of Springfield, Massachusetts, the Blackstone Medical Modular Spinal Fixation System's system of rods and screws were at the heart of the recall. In "layman's terms", some of the screws had a tendency to separate from the screwheads or rods. As a result of these malfunctions, the spine is unable to fuse together and patients could suffer from pain, disability, and the trauma (and cost) of additional surgery.
Though this was a voluntary recall by Blackstone Medical, the FDA classifies the Blackstone Medical Modular Spinal Fixation System recall as a "Class I", the most serious type they issue. When the FDA issues a Class I, the recalled devices, such as the Blackstone Medical Modular Spinal Fixation System, are considered to have a high probability of leading to serious injury or death.
On December 27, 2005, Blackstone Medical sent out a notice to all healthcare professionals about the Blackstone Medical Modular Spinal Fixation System recall, recommending that physicians and surgeons contact any patients who had been given this system and remove the faulty equipment if deemed necessary.
As a follow-up, Blackstone Medical sent out another Blackstone Medical Modular Spinal Fixation System-related press release on April 12, 2006. As noted in the release, "To date, approximately 4% of the constructs have been reported as loose, and this has resulted in the surgical removal or revision of a number of the constructs."
If you or someone you care about was given a Blackstone Medical Modular Spinal Fixation System during unexpected or planned spinal surgery, we urge you to contact our law offices today. As a firm dedicated to the protection of consumers everywhere, we want to represent you and help you collect any monetary compensation you may be due as a result of using this defective product, the Blackstone Medical Modular Spinal Fixation System.
A consultation with one of our knowledgeable legal team members is completely confidential, and you'll owe us no money until we get restitution for you. Call or email us and start the process of claiming what's legally owed to you by the makers of this defective product.