Z-1035-2017 Class II Terminated
FDA device recall Z-1035-2017 was initiated by Endologix on December 27, 2016 and is designated Class II. Reason for recall: 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). The recall status is terminated (terminated April 28, 2017). Affected quantity: 40,967.
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 27, 2016
- Termination Date
- April 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,967
Product Description
AFX Endovascular AAA System, Endoleak Type IIIA
Reason for Recall
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).
Distribution Pattern
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.
Code Information
The correction is not lot specific. It applies to AFX procedures conducted after June 2013