FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly
[RECALL]Jun 15, 2026 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Jun 15, 2026
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.massdevice.com/fda-puts-class-1-label-on-zimmer-biomet-rosa-robotic-arm-recall/
https://www.massdevice.com/fda-puts-class-1-label-on-zimmer-biomet-rosa-robotic-arm-recall/
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Details
Incident Context & FAQ
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.