Z-0100-2018Class II

ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is...

Name: Z-0100-2018 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is...
Creator: Zimmer Biomet, Inc.
Published: 2012-04-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-04-19 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial... on 2012-04-19. FDA classified it as Class II and gives the reason as "Potential failure of the optical distance sensor due to cable disconnection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0100-2018
Classification: Class II
Status: Terminated
Initiated: 2012-04-19
Posted: 2017-11-16
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
Product: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. 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: Potential failure of the optical distance sensor due to cable disconnection.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected customers. Customers were informed on site of the device correction by Field Service Technicians. For questions regarding this recall call 574-267-6131.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Product codes and lots: Serial No. RO10011 and RO10014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0100-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)