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

Recall Z-2108-2018 — ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative pla

U.S. FDA — Device Enforcement · France · 2018-05-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2108-2018
Date of alert: 2018-05-08
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: MEDTECH SAS
Product category: device
Product type: Devices

Reported risk: Replacement of units lacking an updated device approval.

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.

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