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

Recall Z-0638-2018 — ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.

U.S. FDA — Device Enforcement · United States · 2017-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0638-2018
Date of alert
2017-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Robot arm being sent to the wrong position
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.