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.

Previous Synthes Recalls

Synthes is a multi-national medical device company. With offices and research facilities located throughout the world, Synthes specializes in developing and marketing various implants and biomaterials. Company's products include materials used for surgical fixation, as well as implants used to correct and replace damaged parts of the human skeleton. The Synex vertebral replacements were among some of the company's most successful products.

Preliminary reports indicate that Synthes knew about potential health risks several months before the Synex FDA recall. In September, 2009, Synthes sent a warning letter to its sales representatives and hospitals. The company advised physicians to stop implanting Synex II vertebral replacements and to return any unused Synex implants. On November 9, 2009, Synthes sent physicians a follow-up letter asking them to inform patients about potentially serious Synex side effects. However, in November, 2009, the FDA decided that these measures were not enough to protect consumers and issued a Class I Synex recall.

Several other Synthes products have been questioned or recalled before. Recently, the
U.S. Attorney in Pennsylvania filed charges against Synthes stemming from illegal
testing of bone cement that took place from 2002 until 2004. Even though the FDA had
pointed out potential problems and required Synthes to place a special warning on its
bone cement products, the company violated the warnings and tested the product
during spinal surgery. According to the U.S. Attorney's Office, bone cement was tested
on 200 patients, three of whom died during surgery.

* required field

Viles & Beckman, LLC
6350 Presidential Court
Fort Myers, FL 33919

phone:239.334.3933 fax: 239.334.7105