Class 1 Recall of Synthes USA’s Ti Synex VBR Devices. Those Injured by Recalled VBRs Can Obtain Help from our Lawyers.
In November 2009, Synthes USA and the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ti Synex vertebral body replacement (VBR) devices after an investigation of several patients who suffered serious complications after the devices failed.
If you or a loved one experienced a failure of a Synthes VBR device, please complete the form on this page for more information about your legal options.
Between June 2007 and September 2009, Synthes USA produced and marketed eleven different models of their Ti Synex vertebral body replacement (VBR) devices. The devices were designed to help patients who suffered traumatic injuries or had been diagnosed with serious illnesses or other degenerative conditions which caused the thoracic (T1) or lumbar (L5) vertebra to collapse or become unstable.
The recalled devices included:
During this period, the company reviewed FDA adverse event reports, which are submitted to the FDA by healthcare professionals whose patients experience serious side effects related to a medical devices or drug.Incidences of Adverse Events
During this two-year period, Synthes and the FDA received six reports of patients who experienced VBR device failures within six and fifteen months after the devices had been surgically implanted. The device failures led to serious injuries including nerve injury, nerve damage, spinal compression fractures and other injuries that required the patients to undergo additional surgeries. As a result, Synthes and the FDA announced a Class 1 recall of the Ti Synex devices. The FDA issues Class 1 recalls in cases where the use of a medical device or drug places significant risk for the patient to experience serious or potentially fatal side effects.
Contact Our Lawyers for a Free Case Review
If you or a loved one has suffered an injury caused by the implantation of a TI Synex VBR device, our lawyers may be able to help you to seek compensation for your injuries, pain and suffering and other financial compensation.
Please complete the form on this page for a free review of your potential lawsuit. A Weitz & Luxenberg representative will contact you as soon as possible.
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