FDA-Device2016-03-02Class II
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.
Medtronic Neuromodulation
Hazard
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Sold states
Worldwide Distribution, including US Nationwide.
Affected count
51,138 (44,006 US; 9,132 OUS)
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0859-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief