Z-0638-2018Class II

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning...

Name: Z-0638-2018 ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning...
Creator: Zimmer Biomet, Inc.
Published: 2017-05-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-05-01 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used... on 2017-05-01. FDA classified it as Class II and gives the reason as "Robot arm being sent to the wrong position". 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-0638-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Posted: 2018-02-16
Terminated: 2020-07-13
Recalling firm: Zimmer GmbH
Product: ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Robot arm being sent to the wrong position
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.
Quantity in commerce: 16
Distribution: Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Product codes and lots: BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0638-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0638-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-16
Z-0639-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-16

Product code HAW

K172444Class IIROSA BRAIN (v3.0.0.5)Medtech S.A / cleared 2018-03-28

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)