Device recall
Z-1441-2012: OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The…
FDA device recall · Class II · Advanced Bionics Corporation
Key facts
| Recall number (Z-number) | Z-1441-2012 |
|---|---|
| Recall event | 49059 |
| Product | OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator 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 following: failed back surgery… |
| Product code | LGW |
| Recalling firm | Advanced Bionics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2012 |
| PMA numbers | P030017 |
| FEI number | 1000220815 |
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