—#159350

Product

ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K151359
Affected lot / code info: Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021

Why it was recalled

Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.

Root cause (FDA determination)

Software design

Action the firm took

This is a retrospective report of a correction initiated on 20-Jul-2016. Customers were informed onsite by field Service Technicians of the planned correction. The software issue described was corrected in the new software version ROSA Brain 3.0.0.20. Field Service Technicians were deployed to the customers locations to perform the system upgrade. .

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France

Timeline

Recall initiated: 2016-07-20
Terminated: 2020-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159350. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.