Herga foot switch — Class II medical device recall Z-3117-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-09-20, distributed nationwide. Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
| Recall number | Z-3117-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-01-20 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2018-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, DE, ES, FR, GB, IL, IN, IT, RU, SA |
| Quantity | 64 devices |
| Serial numbers | RO08003, RO09004, RO09005, RO10007, RO10009, RO10010, RO10011, RO10013, RO10014, RO11015, RO11016, RO11017, RO12018, RO12019, RO12020, RO12021, RO12022, RO13023, RO13024, RO13025, RO13026, RO13027, RO14029, RO14030, RO14031 and 39 more |
| Model numbers | 2.5.8, 6289-WS |
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
Reason for recall
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3117-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.