Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0859-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2016-01-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0859-2016
Date of alert: 2016-01-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0859-2016 — 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.

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