Specify 5-6-5 Lead — Class II medical device recall Z-0859-2016
Terminated recall by Medtronic Neuromodulation, reported 2016-03-02, distributed nationwide. Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent su
| Recall number | Z-0859-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-01-20 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Model numbers | 39286, 39565 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0859-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.