FDA Device recall Z-0859-2016
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286 by Medtronic Neuromodulation, citing some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0859-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
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.
Reason
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Identifiers
| code_info | All lot/serial numbers are affected for both Model numbers: 39565 and 39286 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0859-2016%22
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