Recalls In Brief
This article was originally published in The Gray Sheet
Executive SummarySynthes recall: Firm is recalling Synex II Central Body components used in its Synex II modular vertebral body replacement system after receiving reports of moderate to severe loss in device height six to 15 months after implantation. The Class I recall could pose "an imminent hazard" to patients, Synthes says, including neural injury, increased pain, spinal kyphosis (a curving of the spine), failure of supplementary fixation, or the need for revision surgery. The firm initiated the global recall Sept. 14, urging surgeons and hospitals to stop implanting the devices and to annually monitor implanted patients through radiographs and pain assessments
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