Class 2 Device Recall Computer Assisted Surgical Device

• Date Initiated by Firm: February 10, 2013
• Create Date: November 28, 2017
• Recall Status: Terminated on June 09, 2020
• Recall Number: Z-0178-2018
• Recall Event ID: 77672
• 510(K)Number: K092239 K101791
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: ROSA Surgical Device 2.5.8
• Code Information: Serial No. RO10011, RO10014, RO13023 and RO13027
• 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: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
• FDA Determined Cause: Software design
• Action: Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.
• Quantity in Commerce: 22 units (4 US and 18 OUS)
• Distribution: AR, 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; 510(K)s with Product Code = HAW