FDA Recalls Synex II Vertebral Body Replacement
In September, Synthes, the manufacturer of Synex II Central Body replacement, issued a voluntary, global recall of the product because it had learned that six of its replacements had failed six to 15 months after implantation. On November 4, 2009, the US Food and Drug Administration (FDA) reclassified the recall as a Class 1 recall, meaning that it was a recall of a product likely to cause immediate serious injury or death.
The Synex II is a spinal replacement implant. It is designed to take the place of a spinal column that has suffered injury or damage, whether from a trauma, tumor, or other cause. They are made of titanium, a highly biocompatible material that is also strong and light. However, the device seems to have been constructed with insufficient strength, and six of them have failed after six to 15 months of use.
The recall covers models with part numbers 04.808.001-011. They were manufactured from June 8, 2007 to September 9, 2009 and distributed from July 2, 2007 to September 8, 2009. If you have been implanted with any of these devices and have increased pain or other unusual symptoms are encouraged to contact their surgeon. Implant failure may result in nerve injury, increase pain, spinal fracture, and may require additional operations to fix.