Recall – Neurosurgery robotic platform software error leads to incorrect arm position, CL I

Company: Zimmer Biomet
Date of Enforcement Report: 11/7/2019
Class I

PRODUCT

The ROSA Brain device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm depending on the procedure to be completed.

  • Recall Number: Z-0172-2020

REASON

Zimmer Biomet recalled the ROSA Brain Device due to a software issue with ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), which can drive the robotic arm to an incorrect position resulting in risks for the patient.

Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported.

RECALLING FIRM/MANUFACTURER

MEDTECH SAS on 9/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

93

DISTRIBUTION

Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.