Class 2 Device Recall ComputerAssisted Surgical Device

• Date Initiated by Firm: September 05, 2014
• Create Date: November 28, 2017
• Recall Status: Terminated on June 09, 2020
• Recall Number: Z-0184-2018
• Recall Event ID: 78362
• 510(K)Number: K092239 K101791
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: ROSA Surgical Device 2.5.8 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 plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
• Code Information: Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
• 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: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
• FDA Determined Cause: Software design
• Action: This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade.
• Quantity in Commerce: 29 (8 US and 21 OUS)
• Distribution: Nationwide Distribution to AK, OH, TX, GA, and MI
• 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; 510(K)s with Product Code = HAW