Recall Z-0859-2016 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
| Date | Jan 11, 2016 |
| Status | Terminated |
| Reason | Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use. |
| Root cause | Labeling design |
| Action | Consignees were sent a Medtronic "Medical Device Correction" letter dated January 2016. The letter was addressed to Healthcare Professional. The letter described the problem and the product involved in the recall. Advised consignees to ensure their staff of the action that is being recommended. Requested consignees to complete and return the "Physician Confirmation Form". For additional information they can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekends 7 am - 6 Pm Central time. |
| Quantity | 51,138 (44,006 US; 9,132 OUS) |
| Distribution | Worldwide Distribution, including US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.