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

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. — recall Z-0160-2018

U.S. FDA — Device Enforcement · United States · 2014-11-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0160-2018
Date of alert
2014-11-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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