ROSA Surgical Device 2 — Class II medical device recall Z-0160-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed in AR, GA, MI, OH, TX. Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather
| Recall number | Z-0160-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-11-06 |
| Classified | 2017-11-20 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-07-13 |
| Distributed | AR, GA, MI, OH, TX |
| Quantity | 31 units |
| Serial numbers | RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037 |
| Model numbers | 2.5.8 |
Product
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Reason for recall
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
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-0160-2018. 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.