Medtronic Neuromodulation: Medical Device Recall in 2016 - (Recall #: Z-0859-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: March 2, 2016

Recall Number: Z-0859-2016

Event ID: 73139

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.

Status: Terminated

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

Code Information:

All lot/serial numbers are affected for both Model numbers: 39565 and 39286

Distribution Pattern:

Worldwide Distribution, including US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated