FDA Recall of Ti Synex II Vertebral Body Replacement
by Marc Stern on Dec.01, 2009
We are currently investigating the FDA’s Class I Recall of the Ti Synex II Vertebral Body Replacement device manufactured by Synthes USA.
The implantable device is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Failure of the central body component resulting in loss of vertebral body replacement height has been reported in some patients.
Potential adverse health effects linked to device failure include nerve injury, increased pain, spinal compression fracture, failure of supplementary fixation, and/or the need for revision surgery. If you’re interested in working with us on this case type, please drop me a note.
-
Get Connected
Receive a sleeve of Titleist ProV1s® when you subscribe to The Business of Law blog. Get the insider's view and share your perspective and insights.
Subscribe Using a Newsreader
