ROSA Spine 1 — Class II medical device recall Z-0639-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-02-28, distributed in CA, DC, FL, IL, KY, MA, MN, NC…. Robot arm being sent to the wrong position
| Recall number | Z-0639-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-05-01 |
| Classified | 2018-02-16 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-07-13 |
| Distributed | CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, PA |
| Quantity | 1 |
Product
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Reason for recall
Robot arm being sent to the wrong position
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-0639-2018. 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.