Device recall
Z-1836-2013: Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-1836-2013 |
|---|---|
| Recall event | 63108 |
| Product | Eon Mini - 3788 (IPG), Eon Mini system 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 | St. Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 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