Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command
[RECALL]Apr 8, 2016 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Apr 8, 2016
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, 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 Surgical Device 2.5.8 over software changing final tool orientation without command?
Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on April 8, 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 Surgical Device 2.5.8 over software changing final tool orientation without command?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command?
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 Surgical Device 2.5.8 over software changing final tool orientation without command?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.