Device recall
Z-1599-2010: Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems…
FDA device recall · Class II · Advanced Neuromodulation Systems, Inc
Key facts
| Recall number (Z-number) | Z-1599-2010 |
|---|---|
| Recall event | 55503 |
| Product | Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 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