Synex II Vertebral Body Replacement

On November 12, 2009 the FDA notified healthcare professionals of a Class I recall of all lots of Synex II Central Body Components from Synthes.

The Class I recall means that the product could pose an imminent health hazard. In situations where the product has been used there are reports of moderate to severe loss of vertebral body replacement height that occurs 6-15 months after the component has been implanted to the patient, which can result in the following:

• Paralysis
• Nerve Injury
• Increased Pain
• Spinal Compression Fracture
• Failure of Additional Fixation
• Need for Reoperation to Modify the Implanted Device

Synex II is an implantable vertebral body replacement device that is used in the thoracolumbar spine (T1-L5 portion of the spine) to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma.

The component subject to recall was distributed between July 2, 2007 and September 8, 2009.

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