Dangerous Products: November 2009 Archives

November 30, 2009

FDA Recalls Defective Synex II Vertebral Body Replacement after Failures

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of Synthes USA's Synex II Vertebral Body Replacement. The Class I recall is the most serious recall and was issued because the medical device presents a reasonable probability of serious injury. The defective medical device, which is used to replace damaged vertebrae in the thoracic and lumbar spine, may fail after implantation causing a loss in the vertebral body replacement height.

According to the FDA, the failure of the device can lead to neural injury, pain, kyphosis, and the need for corrective surgery. Because of the danger associated with this defective medical device, surgeons and hospitals have been ordered to cease using the vertebral body replacements immediately. The defective products subject to recall were manufactured from June 2007 through September 2009. A complete list of the vertebral body replacement part numbers subject to the Class I recall can be found on the FDA's website.

Action by the FDA comes after Synthes USA began recalling the Synex II device in September amidst six adverse incident reports of the vertebral body replacements' failure. Patients with increased pain or other symptoms are advised to contact their surgeon for evaluation. Patients can report adverse incidents to the MedWatch Adverse Event Reporting program established by the FDA.

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