# 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.

## 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

- [Zimmer Biomet](/companies/zimmer-biomet.md)

## Covered models (1)

- [ROSA](/models/zimmer-biomet-rosa.md)

## Related incident

_Recall-is-both seam: this filing is paired with its incident-layer companion when the filing is a recall._

- [Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory](/incidents/rosa-one-brain-trajectory-recall-2021.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm)

_Canonical URL: /regulatory-filings/fda-recall-rosa-one-brain-2021. HTML version: [/regulatory-filings/fda-recall-rosa-one-brain-2021](/regulatory-filings/fda-recall-rosa-one-brain-2021)._