Z-3117-2017Class II

Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device...

Name: Z-3117-2017 Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device...
Creator: Zimmer Biomet, Inc.
Published: 2016-01-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-01-20 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label... on 2016-01-20. FDA classified it as Class II and gives the reason as "Complaints were received reporting the system would freeze/shut down while in Fulgurate 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-3117-2017
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Posted: 2017-09-12
Terminated: 2018-04-30
Recalling firm: Zimmer GmbH
Product: Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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: Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Root cause tag: software
FDA root cause: Software design
Action: Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product. for all surgical procedures, notify and ensure affected personnel are aware of the contents, complete the attached Certificated of Acknowledgement and return a digital copy. Customers with questions were instructed to call +33 (0) 467 107740, US customers should call 800-874-7711, ext 9225 .The initial correction was conducted by the manufacturer on January 20, 2016 with two of the 32 affected units which were imported into the U.S. being corrected by a customer representative. For questions regarding this recall call 574-267-6131.
Quantity in commerce: 64 devices
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom.
Product codes and lots: Serial numbers for ROSA devices with the Herga Footswitch in US distribution: Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15052, RO15053, RO15054, RO15058, RO15059, RO15060, RO15061, RO15062, RO15063, RO15064, RO15067, RO15069, and RO14031. Serial numbers for ROSA devices with the Herga Footswitch in foreign distribution: Serial No. RO08003, RO09004, RO09005, RO10007, RO10010, RO10013, RO11015, RO11016, RO11017, RO12018, RO12019, RO12020, RO12021, RO12022, RO13024, RO13025, RO13026, RO14029, RO14030, RO14032, RO14034, RO14036, RO14042, RO15047, RO15049, RO15055, RO15056, RO15057, RO15065, RO15066, RO15068, and RO15070.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3117-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3117-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

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)