Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position
[RECALL]May 1, 2017 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
May 1, 2017
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Zimmer Biomet recalled the ROSA Spine 1.0.2 robot because the robotic arm could be sent to the wrong position. 1 unit. Source: FDA Class 2 device recall Z-0639-2018, 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 Spine 1.0.2 over the robotic arm being sent to the wrong position?
Zimmer Biomet recalled the ROSA Spine 1.0.2 robot because the robotic arm could be sent to the wrong position. 1 unit. Source: FDA Class 2 device recall Z-0639-2018, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on May 1, 2017 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 Spine 1.0.2 over the robotic arm being sent to the wrong position?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position?
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 Spine 1.0.2 over the robotic arm being sent to the wrong position?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.