Z-0178-2018Class II

ROSA Surgical Device 2.5.8

Name: Z-0178-2018 ROSA Surgical Device 2.5.8
Creator: Zimmer Biomet, Inc.
Published: 2013-02-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-02-10 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Surgical Device 2.5.8 on 2013-02-10. FDA classified it as Class II and gives the reason as "Issue with optional neuro-endoscopy module detected under specific conditions during internal testing". 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-0178-2018
Classification: Class II
Status: Terminated
Initiated: 2013-02-10
Posted: 2017-11-28
Terminated: 2020-06-09
Recalling firm: Zimmer GmbH
Product: ROSA Surgical Device 2.5.8
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Root cause tag: software
FDA root cause: Software design
Action: Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.
Quantity in commerce: 22 units (4 US and 18 OUS)
Distribution: AR, OH, MI, and TX
Product codes and lots: Serial No. RO10011, RO10014, RO13023 and RO13027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0178-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0178-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

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)