Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory
[RECALL]Sep 10, 2019 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Sep 10, 2019
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the instrument holder could follow a trajectory outside the intended target, risking incorrect placement of neurosurgical instruments. Distinct from the 2021 ROSA ONE Brain trajectory recall already recorded. Class I, 93 units. Source: FDA Class I device recall Z-0172-2020, accessdata.fda.gov / openFDA enforcement.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Zimmer&productdescriptiontxt=ROSA&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Zimmer&productdescriptiontxt=ROSA&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100
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Details
Incident Context & FAQ
What happened in Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the instrument holder could follow a trajectory outside the intended target, risking incorrect placement of neurosurgical instruments. Distinct from the 2021 ROSA ONE Brain trajectory recall already recorded. Class I, 93 units. Source: FDA Class I device recall Z-0172-2020, accessdata.fda.gov / openFDA enforcement.
When did this incident occur?
The incident is recorded as occurring on September 10, 2019 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 recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect 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 recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.