FDA recall of surgical implant device

November 13, 2009

The FDA recently recalled all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement. The Synthes USA, Ti Synex II Vertebral Body Replacement is a device used to replace a damaged, collapsed or unstable vertebral body in the spine caused by a fracture or tumor.

The reason for the recall is that there have been reports of moderate to severe loss of verbal body replacement height. The replacement height loss has taken place in patients at 6 to 15 months after the implant was received.

There are numerous serious health risks associated with this loss of replacement height. Side effects range from increased pain to neural injury, and can include the need for another operation.

The FDA has required that all surgeons and hospitals in possession of the Synthes USA, Ti Synex II Vertebral Body Replacement stop implanting these devices immediately.

This is a Class 1 recall, which is the most serious type of all FDA recalls. In a Class 1 recall, there is a reasonable probability that the continued use of the recalled product will result in adverse health consequences or death.

Click here for more information on this FDA recall.

If you or a loved one has suffered pain or injury after using the Synthes USA, Ti Synex II Vertebral Body Replacement, contact Fears | Nachawati today. You’ll receive free legal advice from a Texas personal injury lawyer. Simply email us at info@fnlawfirm.com or call our toll-free number at 1.866.705.7584.

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