Synthes spinal implant recall gets class I notice
This article was originally published in Clinica
Executive Summary
The US FDA has given a class I notification to Synthes’ global recall of a component in its Synex expandable vertebral body replacement device. The Swiss firm, which has a facility in West Chester, Pennsylvania, issued a voluntary recall of the Synex II central body components on September 14 after receiving six adverse event reports connected to the technology. According to Synthes, these reports included moderate to severe loss of vertebral body replacement height, due to failure of the central body component, 6-15 months after implantation. These faults could lead to neural injury, increased pain, spinal kyphosis if unrecognised, failure of supplementary fixation and a need for revisional surgery. The Synex technology is a self-locking implant that is designed to restore spinal alignment using rapid and controlled expansion with minimum instrumentation.