Z-0859-2016Class II

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

Name: Z-0859-2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a...
Creator: Medtronic Neuromodulation
Published: 2016-01-11
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-01-11 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic... on 2016-01-11. FDA classified it as Class II and gives the reason as "Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0859-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-02-23
Terminated: 2017-01-20
Recalling firm: Medtronic Neuromodulation
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 51,138 (44,006 US; 9,132 OUS)
Distribution: Worldwide Distribution, including US Nationwide.
Product codes and lots: All lot/serial numbers are affected for both Model numbers: 39565 and 39286

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0859-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0859-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)