Posted on Wed, Nov. 4, 2009
Medical device maker Synthes Inc., of West Chester, said today that it is recalling some spinal implants that could collapse.
The U.S. Food and Drug Administration has classified the recall of vertebral implants called Synthes Synex II Central Body components as "class I," meaning the products could pose an imminent hazard to health in patients, Synthes said.
Synthes initiated a voluntary recall on Sept. 14, the company said. It said it took action after receiving six reports of patients suffering moderate to severe symptoms six to 15 months after implantation. Potential adverse health issues could include neural injury, increased pain, and a need for additional surgery, the company said.
According to Bloomberg News, Gilgian Eisner, spokesman for Synthes' Zurich-based parent company, said Synthes is trying to determine what is causing the collapse in a small number of patients. An older generation of the devices can still be safely used, he said.
Doctors should step monitoring of patients with the implants, Synthes said. - Reid Kanaley
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