Device recall
Z-2280-2012: Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be…
FDA device recall · Class II · Advanced Neuromodulation Systems Inc.
Key facts
| Recall number (Z-number) | Z-2280-2012 |
|---|---|
| Recall event | 61171 |
| Product | Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs… |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2015 |
| PMA numbers | P010032, P010032S014 |
| FEI number | 1627487 |
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