Synex II Vertebral Replacement System

On September 19, 2009, the U.S. Food and Drug Administration announced a “Class I” recall of the Synex II vertebral replacement system, manufactured by Snythes. This is the FDA’s highest safety precaution and resulted from reports that some devices collapsed 6-15 months after implantation.

This means that every person with a Synex II vertebral replacement system implanted between July 2, 2007, and September 9, 2009, could potentially suffer a serious injury from the failure of the device. These serious injuries include:

• Paralysis
• Nerve Injury
• Increased Pain
• Spinal Compression Fracture
• Failure of Additional Fixation

Worse still, even people that have not experienced a catastrophic failure of the Synex II may need an additional surgery to remove or modify the implanted device. As back surgery is a major operation which requires a lengthy time to recuperate and rehabilitate the back and has many potential complications, many people who trusted that this device would help in their healing may now be forced to undergo another procedure to remedy a problem that should never have happened.

So far there have been six reports of medical device failure in patients with the Synex II vertebral replacement system. In the coming months there are likely to be more people suffering from the collapse of the Synex II.

A Class I recall is the strongest action that the FDA can take. It means there is imminent danger to the health and safety of affected patients. If you have been implanted with the Synex II vertebral replacement system, you should promptly contact your surgeon. Even if the device has not yet collapsed, it could be just a matter of time before tragedy strikes.

Once you secure your health, you may have questions about whether you are entitled to compensation for additional medical care and other harm and damage a defective medical device causes you. If you have these questions, we may have the answers. When you need help moving forward and addressing your situation, you should consult an attorney that understands your situation and can help you get the justice you deserve.

Fill out the free initial contact form below, and take the first steps toward feeling whole again today.