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Incident · Recall

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.

Occurred 2026-06-15 · ROSA at France · Zimmer Biomet · France · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly

Machine-readable surfaces

Sources (2)

  1. https://www.massdevice.com/fda-puts-class-1-label-on-zimmer-biomet-rosa-robotic-arm-recall/
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=176041

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.
What robot was involved in FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
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.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
unclassified
Unclassified source
1
primary-fda-database
FDA database

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

Methodology surface for FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly.

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