Device recall
Z-1275-2013: Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile…
FDA device recall · Class I · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-1275-2013 |
|---|---|
| Recall event | 64975 |
| Product | Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh… |
| Product code | NIU |
| Recalling firm | Cook, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 5, 2013 |
| PMA numbers | P100022 |
| FEI number | 1820334 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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