Class 2 Device Recall ComputerAssisted Surgical Device

• Date Initiated by Firm: June 04, 2014
• Create Date: November 21, 2017
• Recall Status: Terminated on June 16, 2020
• Recall Number: Z-0161-2018
• Recall Event ID: 77750
• 510(K)Number: K092239 K101791
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: ROSA Surgical Device 2.5.8 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 No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Kevin Escaule; 574-267-6131
• Manufacturer Reason for Recall: Software corrections reactivating the cooperative endoscopy mode.
• FDA Determined Cause: Software Design Change
• Action: The firm, Zimmer Biomet Inc., sent Field Service Technicians to consignee locations to perform system upgrade. All US units have been corrected. If you any question, please contact Post Market Surveillance and Regulatory Compliance Director at 574-372-4487 or email to: kevin.escapule@zimmberbiomet.com.
• Quantity in Commerce: 29 devices(8 US and 21 OUS)
• Distribution: Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
• 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