Device recall
Z-2964-2020: Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2964-2020 |
|---|---|
| Recall event | 86242 |
| Product | Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128… |
| Product code | MIH |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2021 |
| FEI number | 1820334 |
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