Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode
[RECALL]Jan 20, 2016 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Jan 20, 2016
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Zimmer Biomet recalled the Herga Foot Switch (model 6289-WS), a component of the ROSA system, because the system could freeze or shut down while in Fulgurate mode. 64 units. Source: FDA Class 2 device recall Z-3117-2017, openFDA enforcement / accessdata.fda.gov.
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 Herga Foot Switch over system freeze or shutdown in Fulgurate mode?
Zimmer Biomet recalled the Herga Foot Switch (model 6289-WS), a component of the ROSA system, because the system could freeze or shut down while in Fulgurate mode. 64 units. Source: FDA Class 2 device recall Z-3117-2017, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on January 20, 2016 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 Herga Foot Switch over system freeze or shutdown in Fulgurate mode?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode?
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 Herga Foot Switch over system freeze or shutdown in Fulgurate mode?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.