Recall Z-0055-2008 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Bionics Corp
Precision Implantable Pulse Generator (IPG), Model Number SC-110
| Date | Oct 12, 2007 (initiated Aug 3, 2007) |
| Status | Terminated |
| Reason | Mislabeled: Product labeled with the incorrect shelf-life information. |
| Root cause | Error in labeling |
| Action | There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company. |
| Quantity | 1 unit affected |
| Distribution | MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.