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FDA says recalled Synthes devices are health hazard

Wed Nov 4, 2009 10:53pm IST
 
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* Synex II Central Body components classified as Class I

* Company recalled devices globally on Sept. 14

* Company says implants must stop immediately

ZURICH, Nov 5 (Reuters) - The U.S. Food and Drug Administration has classified a recall of Synthes' (SYST.VX: Quote, Profile, Research) Synex II Central Body components as Class I, meaning the products could pose an imminent health hazard.

Swiss medical device company Synthes voluntarily recalled all Synthex II Central Body components on Sept. 14 following six adverse event reports.

"Synthes advises that surgeons and hospitals in possession of the subject devices must stop implanting them immediately," the company said in a statement.

The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium. (Writing by Lisa Jucca; Editing by Jon Loades-Carter)

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