Date Initiated by Firm |
January 11, 2016 |
Create Date |
February 23, 2016 |
Recall Status1 |
Terminated 3 on January 20, 2017 |
Recall Number |
Z-0859-2016 |
Recall Event ID |
73139 |
PMA Number |
P840001S096 P840001S126 |
Product Classification |
Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
|
Product |
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. |
Code Information |
All lot/serial numbers are affected for both Model numbers: 39565 and 39286 |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 7000 Central Ave Ne Minneapolis MN 55432-3568
|
For Additional Information Contact |
Medtronic Neuromodulation 800-707-0933
|
Manufacturer Reason for Recall |
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
|
FDA Determined Cause 2 |
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 in Commerce |
51,138 (44,006 US; 9,132 OUS) |
Distribution |
Worldwide Distribution, including US Nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = LGW and Original Applicant = MEDTRONIC NEUROMODULATION
|