_Incident · Recall_

# FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly

Canonical ID: `bd46942b-2550-42d5-9b3f-e27dedd33251`

- **Occurred:** 2026-06-15
- **Kind:** `recall`
- **Status (derived):** active
- **Company:** [Zimmer Biomet](/companies/zimmer-biomet.md) (id: `bf360924-7c7c-4b17-8fcf-8abf5950c0ff`)

FDA Class I recall for Zimmer Biomet ROSA Brain 3.0 robotic surgery system. Software issue can cause robotic arm to move to incorrect position during neurosurgery. 86 units affected in the US. Most serious recall type.

## Sources (1)

1. https://www.massdevice.com/fda-puts-class-1-label-on-zimmer-biomet-rosa-robotic-arm-recall/

## Status history

- **active** · 2026-07-03 · agent:depth

## Common questions

### What happened in FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly?

FDA Class I recall for Zimmer Biomet ROSA Brain 3.0 robotic surgery system. Software issue can cause robotic arm to move to incorrect position during neurosurgery. 86 units affected in the US. Most serious recall type.

### When did this incident occur?

The incident is recorded as occurring on June 15, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly?

The incident is recorded as involving Zimmer Biomet on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### Has anyone responded to FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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