Z-1047-2017 Class II Terminated
FDA device recall Z-1047-2017 was initiated by Endologix on December 27, 2016 and is designated Class II. Reason for recall: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). The recall status is terminated (terminated April 28, 2017).
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
Product Description
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Reason for Recall
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Distribution Pattern
US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Code Information
The correction is not lot specific. It applies to AFX procedures conducted after October 2015