DEPLOYDatabase

Incident · Recall

Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position

Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the robotic arm could be sent to the wrong position. 16 units. Source: FDA Class 2 device recall Z-0638-2018, openFDA enforcement / accessdata.fda.gov.

Occurred 2017-05-01 · ROSA at France · Zimmer Biomet · France · Surgical robots · Investigated by FDA

How to read this record

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 Brain 3.0 over the robotic arm being sent to the wrong position

Machine-readable surfaces

Sources (2)

  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=160939

Common questions

What happened in Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position?
Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the robotic arm could be sent to the wrong position. 16 units. Source: FDA Class 2 device recall Z-0638-2018, 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 Brain 3.0 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 Brain 3.0 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 Brain 3.0 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.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
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 Brain 3.0 over the robotic arm being sent to the wrong position.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

Canonical ID cdc6c5a0-d046-4fd3-a7b2-e065009851fe