Device recall
Z-2235-2009: Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-2235-2009 |
|---|---|
| Recall event | 50473 |
| Product | Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped… |
| Product code | NVZ |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| PMA numbers | P950029 |
| FEI number | 2182863 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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