_Incident · Recall_

# Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory

Canonical ID: `186fb155-6c2e-4812-907c-fd241200cad9`

- **Occurred:** 2021-09-22
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [ROSA](/models/zimmer-biomet-rosa.md) (id: `deb70c72-adc4-4912-b3f3-cddee712e118`)

Class I recall (urgent correction Sep 22 2021; FDA Class I designation Nov 2021): on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke/serious-injury risk). 119 US devices; 3 complaints (one inaccurate electrode placement); no injuries reported. Software corrective update rolled out 2022.

## Sources (2)

1. **FierceBiotech** · https://www.fiercebiotech.com/medtech/zimmer-biomet-issues-class-i-recall-rosa-one-robotic-neurosurgery-platform-due-to-software
2. **Becker's** · https://www.beckersspine.com/robotics/zimmer-biomet-recalls-surgical-robot/

## Common questions

### What happened in Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?

Class I recall (urgent correction Sep 22 2021; FDA Class I designation Nov 2021): on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke/serious-injury risk). 119 US devices; 3 complaints (one inaccurate electrode placement); no injuries reported. Software corrective update rolled out 2022.

### When did this incident occur?

The incident is recorded as occurring on September 22, 2021 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### What robot was involved in Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?

ROSA is the recorded robot involved in this incident.

### Has anyone responded to Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?

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 Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?

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


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