Device recall
Z-0113-2009: Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm…
FDA device recall · Class II · Cook Endoscopy
Key facts
| Recall number (Z-number) | Z-0113-2009 |
|---|---|
| Recall event | 49518 |
| Product | Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree. |
| Product code | FGE |
| Recalling firm | Cook Endoscopy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2009 |
| 510(k) numbers | K020788 |
| FEI number | 1037905 |
At a glance
- 1–9 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