Medtronic Neuromodulation recalls Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimu

Recalled March 2, 2016 · FDA recall Z-0859-2016 · 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. · FDA Class II

Units

51,138 (44,006 US; 9,132 OUS)

Sold at

Worldwide Distribution, including US Nationwide.

Description

Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.

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.

Manufacturer(s)

Medtronic Neuromodulation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →