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FDA Classifies Synthes Device Recall as Class I

Regulators have classified a recall of Synthes’ Synex II Central Body components as Class I, which means the product could impose an imminent hazard to patients’ health. This news comes after the U.S. Food and Drug Administration received six adverse event reports.

These reports included moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) at six to 15 months after implantation. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for re-operation/revision surgery.

Synthes advises that surgeons and hospitals in possession of the device must stop implanting them immediately, and physicians should contact Synthes for return instructions.

The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

Physicians with questions related to this medical device recall should contact Synthes, based in West Chester, Pa., at (800)620-7025, ext.5375. Any adverse reactions/events experienced with use of the Synex II Central Body devices should be reported to Synthes at (800) 752-0128, orComplaintUnit@synthes.com.