Class 2 Device Recall ComputerAssisted Surgical Device

• Date Initiated by Firm: April 08, 2016
• Create Date: November 18, 2017
• Recall Status: Terminated on July 13, 2020
• Recall Number: Z-0115-2018
• Recall Event ID: 77743
• 510(K)Number: K101791
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: ROSA Surgical Device 2.5.8
• Code Information: Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
• 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: Potential for software to change the final tool orientation for the command position without command.
• FDA Determined Cause: Software design
• Action: Field Service Technicians visited consignee locations to perform system upgrades and have been completed.
• Quantity in Commerce: 64 units
• Distribution: AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
• 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 and Original Applicant = MEDTECH SAS