Device recall
Z-1049-2017: AFX2 Endovascular AAA System Item No. Item Description F00820-01…
FDA device recall · Class II · Endologix
Key facts
| Recall number (Z-number) | Z-1049-2017 |
|---|---|
| Recall event | 76256 |
| Product | AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30… |
| Product code | MIH |
| Recalling firm | Endologix |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2017 |
| PMA numbers | P040002 |
| FEI number | 3011063223 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database