FDAFDA · Food and drugs·Recall number Z-1035-2017
AFX Endovascular AAA System, Endoleak Type IIIA
Published January 25, 2017 · Recall initiated: December 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endologix
- Distributor
- Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
- Lot
- The correction is not lot specific. It applies to AFX procedures conducted after June 2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.