ROSA Surgical Device 2 — Class II medical device recall Z-0102-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-22, distributed in MI, OH, TX. An undetected shift between the information displayed in the navigation software and the actual patient anatom
| Recall number | Z-0102-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2020-09-16 |
| Distributed | MI, OH, TX |
| Reason classes | software |
| Serial numbers | RO10009, RO10011, RO10014, RO13023 |
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
Reason for recall
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
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-0102-2018. 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.