Wednesday, November 4, 2009

Synthes: The New Model Citizen!

I guess Synthes has learned its lesson about doing things the right way. Unfortunately, it took litigation on behalf of the DOJ and three untimely deaths to teach them a lesson. Today, Synthes announced that the FDA has classified a recall of the Synex II as a Class I device. Essentially meaning that this products poses an imminent hazard to the health of a patient if this device was implanted.

The voluntary recall, unlike Norian, was initiated after six adverse events were reported related to this device. The reports note that there was moderate to severe loss of vertebral body replacement height, meaning the central body component was failing to hold up six to fifteen months post-op. Adverse issues include neural injury, increased pain, spinal kyphosis, failure of supplemental fixation, and need for revision surgery.

Synthes has advised their customers to cease and desist utilizing this product. Patients that have had this device implanted should speak to their physicians immediately. If you know of anyone that has had this device implanted please pass this on notification on to them immediately.

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