ROSA Surgical Device 2 — Class II medical device recall Z-0161-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed nationwide. Software corrections reactivating the cooperative endoscopy mode.
| Recall number | Z-0161-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-06-04 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, DE, ES, FR, IL, IT, RU, SA |
| Reason classes | software |
| 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 4 more |
Product
ROSA Surgical Device 2.5.8 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
Software corrections reactivating the cooperative endoscopy 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-0161-2018. 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.