Z-0115-2018Class II

ROSA Surgical Device 2.5.8

Name: Z-0115-2018 ROSA Surgical Device 2.5.8
Creator: Zimmer Biomet, Inc.
Published: 2016-04-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-04-08 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of ROSA Surgical Device 2.5.8 on 2016-04-08. FDA classified it as Class II and gives the reason as "Potential for software to change the final tool orientation for the command position without command". 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-0115-2018
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Posted: 2017-11-18
Terminated: 2020-07-13
Recalling firm: Zimmer GmbH
Product: ROSA Surgical Device 2.5.8
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Potential for software to change the final tool orientation for the command position without command.
Root cause tag: software
FDA root cause: Software design
Action: Field Service Technicians visited consignee locations to perform system upgrades and have been completed.
Quantity in commerce: 64 units
Distribution: AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
Product codes and lots: Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0115-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18

Product code HAW

K101791Class IIRosa Surgical DeviceMedtech S.A.S / cleared 2010-09-23

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)