Class 2 Device Recall ComputerAssisted Surgical Device

• Date Initiated by Firm: May 27, 2016
• Create Date: November 17, 2017
• Recall Status: Terminated on June 16, 2020
• Recall Number: Z-0105-2018
• Recall Event ID: 77742
• 510(K)Number: K101791
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: 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.
• Code Information: Serial No. BR16004, BR15002, and BR15003
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Kevin Escapule; 574-267-6131
• Manufacturer Reason for Recall: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
• FDA Determined Cause: Process control
• Action: Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.
• Quantity in Commerce: 3 units
• Distribution: Worldwide Distribution - US (DC) and Internationally to Australia and France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HAW