Blackstone Medical - ICON Modular Fixation System Overview

Blackstone Medical, Inc., of Wayne, New Jersey has taken part in the overall advancement of medical technology over the years. The company has released several promising products into the marketplace, and one specific product that offered a high degree of hope was the ICON Modular Fixation System.

This product hit the market in June of 2005, and its primary use was to allow surgeons to assemble a construct made of screws, connectors and rods to be used in spinal surgery. The purpose was to create a stabilizing effect on patients as surgeons performed surgery on or around the spinal column. This stabilization would allow for faster, safer healing by the patients as they recovered from different types of procedures.

Product Uses for ICON Modular Fixation System.

After a few months on the market, problems with the ICON Modular Fixation System began to arise. A general description of these problems always started with the tendency for this construct to loosen inside of the patient's body soon after the recovery process from the original surgery had begun.

This loosening created the potential for serious injuries, as any foreign object that exists near the spinal cord that can not be trusted to function properly carries a significant degree of danger. Specifically, damage to the spinal cord can cause weakening and numbing of limbs and extremities and even partial or total paralysis. The exact type of injuries that could occur as a result of a loose construct can not be identified in a finite manner, as this product was used in surgeries located all over the spinal area of patients.

FDA Recall Issued Blackstone Medical Inc.

On December 27, 2005, Blackstone Medical, Inc. informed the FDA of its intent to initiate a recall of this product. That same day, Blackstone Medical, Inc. sent notice to surgeons and distributors warning them of this issue. Since then, no product with these specifications has been used.

On April 7, 2006, the FDA classified this recall as a “Class I” recall, which is the most serious within this category. Although at the time of reporting no serious injuries or deaths had been reported, a Class I recall by definition means that the product in question carries the potential for serious injuries and death.

If you had spinal surgery at any time between June and December of 2005, or even in the months that immediately followed, and this construct was used in your surgery, contact your doctor immediately to find out if you are at risk for injury.

If you are at risk, or you have suffered injuries as a result of using this product, you also need to contact an experienced trial attorney as soon as possible for a full consultation. You may have rights and a claim that need to be enforced, but you only have a certain amount of time to do so. Contact an attorney today