Class I Recall Issued for Synthes USA, Ti Synex II Vertebral Body Replacement

Wahsington, DC: The 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) in situ at six to fifteen months post implantation were received.

This recall is being issued because loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.

This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

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Published on Nov-13-09