Z-0177-2018Class II

Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the...

Name: Z-0177-2018 Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the...
Creator: Zimmer Biomet, Inc.
Published: 2015-10-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-10-29 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument... on 2015-10-29. FDA classified it as Class II and gives the reason as "A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device". 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-0177-2018
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Posted: 2017-11-28
Terminated: 2020-06-16
Recalling firm: Zimmer GmbH
Product: Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Root cause tag: software
FDA root cause: Software design
Action: Zimmer Biomet issued a retrospective report of a correction taken on 29-Oct-2015. The software issue described was corrected in the new software version 1.0.2.16. There were 2 copies of the affected software in distribution. Field Service Technicians were deployed to the consignee locations to perform the system upgrade. 100% of affected devices were updated with the software solution. No further action is required.
Quantity in commerce: 2
Distribution: Worldwide Distribution including France and Germany
Product codes and lots: Serial #'s; SP14003 and SP14005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0177-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0177-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

Product code OLO

K151511Class IIROSA SpineMedtech S.A / cleared 2016-01-04

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)