Litigation

Vertebral Body Replacement Recall

Attorneys Mark Zamora at 877-574-6454 and Rob Bunch at 888-422-2882 are investigating links between this recall and injuries

FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component)  at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.

Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

Full post as published by Trial Lawyer Resource Center on November 17, 2009 (boomark / email).