Class 2 Device Recall ROSA Surgical Device 2.5.8

• Date Initiated by Firm: February 14, 2014
• Create Date: November 16, 2017
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-0102-2018
• Recall Event ID: 78372
• 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
• Code Information: Serial #s; RO10009, RO10011, RO10014, and RO13023
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Mr. Kevin W. Escapule; 574-267-6131
• Manufacturer Reason for Recall: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
• FDA Determined Cause: Error in labeling
• Action: There were 4 units imported into the US and all have been corrected.
• Quantity in Commerce: 21 (4 US and 17 OUS)
• Distribution: 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