Device recall
Z-1039-2012: S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1039-2012 |
|---|---|
| Recall event | 61098 |
| Product | S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent… |
| Product code | FGE |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2014 |
| 510(k) numbers | K031777 |
| FEI number | 1016427 |
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