Device recall
Z-1983-2012: Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as…
FDA device recall · Class II · Advanced Neuromodulation Systems Inc.
Key facts
| Recall number (Z-number) | Z-1983-2012 |
|---|---|
| Recall event | 61151 |
| Product | Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2015 |
| PMA numbers | P010032, P010032S023 |
| 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