Device recall
Z-1040-2012: S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1040-2012 |
|---|---|
| Recall event | 61098 |
| Product | S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is… |
| Product code | NIO |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2014 |
| PMA numbers | P020036 |
| FEI number | 1016427 |
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