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Incident · Recall

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.

Occurred 2021-09-22 · ROSA

Machine-readable surfaces

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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-06-04

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-06-04

Sources by quality tier

2
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for 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