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

Recall Z-2396-2019 — AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitor

U.S. FDA — Device Enforcement · United States · 2019-04-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2396-2019
Date of alert: 2019-04-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ad-Tech Medical Instrument Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 208140699

Reported risk: An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.

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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