Home » Synthes USA Recalls Vertebral Body Replacement
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.
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