Device recall
Z-2579-2010: Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-2579-2010 |
|---|---|
| Recall event | 56199 |
| Product | Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy |
| Product code | NIK |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2012 |
| PMA numbers | P060027 |
| FEI number | 2182863 |
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