Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting
[RECALL]Nov 6, 2014 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Nov 6, 2014
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
A ROSA robot (software 2.5.8) was recalled because a force-feedback sensor failure could prevent the robotic arm from stopping as intended. 31 units. Source: FDA Class 2 device recall Z-0160-2018, 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 ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting?
A ROSA robot (software 2.5.8) was recalled because a force-feedback sensor failure could prevent the robotic arm from stopping as intended. 31 units. Source: FDA Class 2 device recall Z-0160-2018, accessdata.fda.gov / openFDA enforcement.
When did this incident occur?
The incident is recorded as occurring on November 6, 2014 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 ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting?
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 ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.