Class 2 Device Recall ROSA ComputerAssisted Surgical Device

• Date Initiated by Firm: November 06, 2014
• Create Date: November 20, 2017
• Recall Status: Terminated on July 13, 2020
• Recall Number: Z-0160-2018
• Recall Event ID: 77626
• 510(K)Number: K101791 K092239
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
• Code Information: Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Kevin W Escapule; 574-267-6131
• Manufacturer Reason for Recall: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
• FDA Determined Cause: Device Design
• Action: All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.
• Quantity in Commerce: 31 units
• Distribution: US distribution in AR, GA, OH, MI, and TX.
• 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 S.A.; 510(K)s with Product Code = HAW and Original Applicant = MEDTECH SAS