Z-2868-2017Class II

ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or...

Name: Z-2868-2017 ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or...
Creator: Zimmer Biomet, Inc.
Published: 2016-10-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-10-11 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide... on 2016-10-11. FDA classified it as Class II and gives the reason as "Complaint of the head holder connector locking up mechanically when tightened". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2868-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-11
Posted: 2017-08-03
Terminated: 2020-06-29
Recalling firm: Zimmer GmbH
Product: ROSA Brain, 3.0.0 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: Complaint of the head holder connector locking up mechanically when tightened.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Product was/will be corrected by Field Technician staff in the form of a visit.
Quantity in commerce: 20 units (16 US, 4 OUS)
Distribution: Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
Product codes and lots: Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2868-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2868-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-03

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)