Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability

[RECALL]

Feb 5, 2013 · Zimmer Biomet · ROSA · France

Failure Mode

RECALL

Event Date

Feb 5, 2013

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 over observed device instability. 53 units. Source: FDA Class 2 device recall Z-0099-2018, openFDA enforcement / accessdata.fda.gov.

System & Fleet Architecture

Operating Manufacturer

Zimmer BiometView Manufacturer

Hardware Platform

ROSA

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • 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

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability?

Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 over observed device instability. 53 units. Source: FDA Class 2 device recall Z-0099-2018, openFDA enforcement / accessdata.fda.gov.

When did this incident occur?

The incident is recorded as occurring on February 5, 2013 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 observed device instability?

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 observed device instability?

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 observed device instability?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.