Class 1 Device Recall ROSA Brain 3.0

• Date Initiated by Firm: September 10, 2019
• Date Posted: November 01, 2019
• Recall Status: Terminated on November 02, 2021
• Recall Number: Z-0172-2020
• Recall Event ID: 83665
• 510(K)Number: K151359 K172444
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.
• Code Information: BR16004 BR16005 BR16006 BR16009 BR16010 BR16011 BR16012 BR16012 BR16014 BR16015 BR16016 BR16017 BR16018 BR16021 BR16023 BR16025 BR17030 BR17034 BR17035 BR17036 BR17037 BR18024 BR18031 BR18038 BR18039 BR18040 BR18041 BR18042 BR18043 BR18045 BR18046 BR18047 BR18048 BR18049 BR18050 BR18051 BR18052 BR18053 BR18054 BR18055 BR18056 BR18057 BR18058 BR18059 BR18060 BR18061 BR18062 BR18063 BR18064 BR18065 BR18066 BR18067 BR18068 BR18069 BR18070 BR18071 BR18072 BR18073 BR18074 BR18075 BR18076 BR18077 BR18078 BR18079 BR18080 BR18081 BR18082 BR18083 BR18084 BR18085 BR18086 BR18087 BR18088 BR18089 BR18090 BR18091 BR18092 BR18093 BR18094 BR18095 BR18096 BR18097 BR18098 BR18099 BR18100 BR18101 BR15002 BR15003 BR16019 BR16028 BR16029 BR16026 BR16032
• Recalling Firm/ Manufacturer: MEDTECH SAS; 900 Rue Du Mas De Verchant; Montpellier France
• For Additional Information Contact: Perry Twyford; 281-3893236
• Manufacturer Reason for Recall: The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
• FDA Determined Cause: Software in the Use Environment
• Action: On September 10, 2019, the firm issued an Urgent Medical Device Correction to customers, advising them of the product issue. The customer notification included instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur. The firm stated that they would provide a label containing the workaround instructions that could be applied directly to the unit by September 30, 2019. A Zimmer Biomet engineer will be deployed to each customer site to implement a new software version to correct the issue. Customers will be contacted by 10/31/19 with additional information regarding this planned update and the estimated timing. For surgeons, there are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow-up schedule. If you have further questions or concerns after reviewing this notice, please call Perry Twyford at 281-389-3236 between 9:00 am and 6:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 93
• Distribution: Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.
• 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