Synthes USA Recalls Vertebral Body Replacement

Synthes USA is recalling all lots of its Ti Synex II vertebral body replacement, an action the FDA considers a Class I recall. The product is used in the T1-L5 portion of the spine to replace a collapsed, damaged or unstable vertebral body. The devices were distributed from July 2, 2007, to Sept. 8 and are being recalled because a loss of device height six to 15 months following surgery may result in nerve injury, increased pain, spinal compression fracture or failure of additional fixation, according to an FDA statement.