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.


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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