Device recall
Z-2099-2017: Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular…
FDA device recall · Class I · Cook Medical Incorporated
Key facts
| Recall number (Z-number) | Z-2099-2017 |
|---|---|
| Recall event | 77099 |
| Product | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: "… |
| Product code | MIH |
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 14, 2019 |
| PMA numbers | P140016 |
| FEI number | 3005580113 |
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