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

Recall Z-2120-2020 — Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are p

U.S. FDA — Device Enforcement · United States · 2019-04-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2120-2020
Date of alert: 2019-04-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Neuromodulation Corporation
Product category: device
Product type: Devices

Reported risk: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

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

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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.

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