Vertebral Body Replacement Device Recalled

The U.S. FDA has recalled the Sythes USA T1 Synex II vertebral body replacement, a device used to replace intervertebral discs from T1-L5 because of failure after 6-15 months of spacing height. All disc replacements were manufactured from June 2007-September 2009 and are no longer to be implanted. The failure can be associated with neural injury, increased pain and kyphosis.

Periodic follow-up of patients with the device are recommended with annual x-rays and clinical reassessment.

See the FDA MedWatch website or phone 1-800-620-7025 extentionn 5375 for more details.