ABC News

FDA Says Recalled Synthes Devices Are Health Hazard

ZURICH (Reuters) - The U.S. Food and Drug Administration has classified a recall of Synthes' 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 Synex II Central Body components on September 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)

Copyright 2009 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

  • 1
Next Story: The Senate Health Bill: What You Need to Know
Comment & Contribute

Do you have more information about this topic? If so, please click here to contact the editors of ABC News.

Watch Video
1 2 3 4
Health News
Slideshows
1
Click Here