Device recall
Z-0595-06: Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated…
FDA device recall · Class II · Endologix Inc
Key facts
| Recall number (Z-number) | Z-0595-06 |
|---|---|
| Recall event | 34219 |
| Product | Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL |
| Product code | MIH |
| Recalling firm | Endologix Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2012 |
| PMA numbers | P040002 |
| FEI number | 1000125107 |
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