Regulatory filing
fda_recall (us_fda)
Class I recall of the Zimmer Biomet ROSA ONE Brain 3.1 where software could drive the arm along an unintended trajectory; 2021.
fda recall · recalled · decided 2021-10-29
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-recall-rosa-one-brain-2021.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/c08e6b1f-f559-40f6-bd97-39c7fc610ef9
- Revision history: /regulatory-filings/fda-recall-rosa-one-brain-2021/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda recall
- Status
- recalled
- Filing date
- 2021-09-22
- Decision date
- 2021-10-29
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
c08e6b1f-f559-40f6-bd97-39c7fc610ef9