Replacement Device Recalled due to Possible Harmful Side Effects

November 13, 2009

A replacement device for damaged spine could have harmful side effects to the body prompting the US Food and Drug Administration (FDA) to recall the products the other day.

Class I recall for Synthes USA’s Ti Synex II Vertebral Body Replacement product was ordered immediately by FDA.

The T1-L5 part of the spine can possibly have a moderate to severe loss of vertebral body replacement height. It takes place after the surgery within six to fifteen months. Increase pain, nerve injury, spinal compression fracture and malfunction of added fixation may take place. It might require another operation to fix the Ti Synex II Vertebral Body Replacement.

FDA advised those who underwent this type of surgery replacement to report any side effects of the implant to their doctors immediately.

The devices made from June 2007 to September 2009 that were distributed on those months were recalled.