ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
FDA Recall Z-0105-2018 · Posted None
Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2016-05-27
Date Terminated2020-06-16
Product Quantity3 units
Reason for Recall
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Firm Action
Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (DC) and Internationally to Australia and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.