Z-0105-2018Class II

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to...

Name: Z-0105-2018 ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to...
Creator: Zimmer Biomet, Inc.
Published: 2016-05-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-05-27 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard... on 2016-05-27. FDA classified it as Class II and gives the reason as "Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device". 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-0105-2018
Classification: Class II
Status: Terminated
Initiated: 2016-05-27
Posted: 2017-11-17
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
Product: ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution - US (DC) and Internationally to Australia and France.
Product codes and lots: Serial No. BR16004, BR15002, and BR15003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0105-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0105-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-17

Product code HAW

K101791Class IIRosa Surgical DeviceMedtech S.A.S / cleared 2010-09-23

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)