Z-0161-2018Class II

ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and...

Name: Z-0161-2018 ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and...
Creator: Zimmer Biomet, Inc.
Published: 2014-06-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-06-04 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide... on 2014-06-04. FDA classified it as Class II and gives the reason as "Software corrections reactivating the cooperative endoscopy mode". 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-0161-2018
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Posted: 2017-11-21
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
Product: ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Software corrections reactivating the cooperative endoscopy mode.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm, Zimmer Biomet Inc., sent Field Service Technicians to consignee locations to perform system upgrade. All US units have been corrected. If you any question, please contact Post Market Surveillance and Regulatory Compliance Director at 574-372-4487 or email to: [email protected].
Quantity in commerce: 29 devices(8 US and 21 OUS)
Distribution: Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
Product codes and lots: Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code HAW

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)