Synthes FDA Recall for the Synex II Vertebral Body Replacement

On November 12, 2009, the FDA issued a Class I recall of Synthes vertebral body replacement products. These medical devices are used to replace damaged vertebrae throughout the spine. The Synthes FDA recall was prompted by six reports revealing that the company's vertebral replacements had collapsed inside patient's spines only months after implantation. Class I recall is the strongest type of recall that the FDA issues when a medical device poses harm of causing serious injury or death.

Synthes recall involves a vertebral replacement technology labeled Ti Synex II Central Body Replacement. The recall includes all lots of the titanium Synex II vertebral replacements with part numbers 04.808.001 - 0111. The defective products were manufactured and distributed in the United States from June, 2007, to September, 2009.

Signs of Synex side effects include increased pain in the back and limited range of motion. If not diagnosed and corrected promptly, a defective vertebral replacement can lead to neural injury, spinal kyphosis (abnormal curve in the spine), and spinal compression fracture. As a result, Synex patients might need additional surgery to replace or modify the implant.  

If you have undergone vertebral replacement surgery with Synex II implant and suspect that this product has caused pain or other symptoms, you might be entitled to compensation. Please contact us to discuss your situation and determine whether you could benefit from filing a Synthes lawsuit.

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