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

Recall Z-0167-2018 — ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any

U.S. FDA — Device Enforcement · United States · 2016-07-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0167-2018
Date of alert: 2016-07-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.

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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