ROSA Surgical Device 2 — Class II medical device recall Z-0184-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-12-06, distributed nationwide. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
| Recall number | Z-0184-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-09-05 |
| Classified | 2017-11-28 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035 |
Product
ROSA Surgical Device 2.5.8 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
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
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-0184-2018. 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.