Z-0116-2018Class II

Rosa Brain 3.0.0

Name: Z-0116-2018 Rosa Brain 3.0.0
Creator: Zimmer Biomet, Inc.
Published: 2016-07-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-07-29 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of ROSA BRAIN 3.0.0 on 2016-07-29. FDA classified it as Class II and gives the reason as "Non-conforming product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0116-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Posted: 2017-11-18
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
Product: Rosa Brain 3.0.0
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Non-conforming product label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: All affected devices received a corrected label. Correction notification and implementation were performed by field technicians.
Quantity in commerce: 2 devices
Distribution: OH and PA.
Product codes and lots: Serial No. BR16017 and BR16018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18

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)