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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.

Occurred 2016-01-20 · 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 Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode

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Sources (3)

  1. 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
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=156850
  3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?event_id=77614&start_search=1

Common questions

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.
Methodology: Verified · 3 sources (3 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

3
primary-fda-database
FDA database

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

Methodology surface for Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode.

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Canonical ID 23972479-44dd-4205-8715-c92f2799a784