Recall Z-0299-2007 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Bionics Corporation
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
| Date | Jan 10, 2007 (initiated Sep 21, 2006) |
| Status | Terminated |
| Reason | A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient. |
| Root cause | Other |
| Action | In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units. |
| Quantity | 18 |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.