ROSA Surgical Device 2 — Class II medical device recall Z-0115-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed in AL, AR, CA, CO, CT, FL, GA, KY…. Potential for software to change the final tool orientation for the command position without command.
| Recall number | Z-0115-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-04-08 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-07-13 |
| Distributed | AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, WA |
| Countries outside the US | CA, CN, DE, ES, FR, GB, IL, IN, IT, RU, SA |
| Quantity | 64 units |
| Reason classes | software |
| Serial numbers | RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15052, RO15053, RO15054, RO15058, RO15059 and 7 more |
Product
ROSA Surgical Device 2.5.8
Reason for recall
Potential for software to change the final tool orientation for the command position without command.
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-0115-2018. 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.