Z-0167-2018Class II

ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument...

Name: Z-0167-2018 ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument...
Creator: Zimmer Biomet, Inc.
Published: 2016-07-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-07-20 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2016-07-20. FDA classified it as Class II and gives the reason as "Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0167-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Posted: 2017-11-21
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.
Root cause tag: software
FDA root cause: Software design
Action: 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. .
Quantity in commerce: 18 (14 US and 4 OUS)
Distribution: Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
Product codes and lots: Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0167-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0167-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code HAW

K151359Class IIROSA BrainMedtech S.A / cleared 2015-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)