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

Recall Z-0102-2018 — ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

U.S. FDA — Device Enforcement · United States · 2014-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0102-2018
Date of alert
2014-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
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.

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