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Incident · Recall

Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory

Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the instrument holder could follow a trajectory outside the intended target, risking incorrect placement of neurosurgical instruments. Distinct from the 2021 ROSA ONE Brain trajectory recall already recorded. Class I, 93 units. Source: FDA Class I device recall Z-0172-2020, accessdata.fda.gov / openFDA enforcement.

Occurred 2019-09-10 · Zimmer Biomet · Investigated by FDA

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Track Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory

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Sources (1)

  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

Common questions

What happened in Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
Zimmer Biomet recalled the ROSA Brain 3.0 stereotactic neurosurgery robot because the instrument holder could follow a trajectory outside the intended target, risking incorrect placement of neurosurgical instruments. Distinct from the 2021 ROSA ONE Brain trajectory recall already recorded. Class I, 93 units. Source: FDA Class I device recall Z-0172-2020, accessdata.fda.gov / openFDA enforcement.
When did this incident occur?
The incident is recorded as occurring on September 10, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
The incident is recorded as involving Zimmer Biomet on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory?
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 (Class I) over instrument holder following an incorrect trajectory?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
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 (Class I) over instrument holder following an incorrect trajectory.

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Canonical ID a2203264-7460-46e5-bd2c-a9ecb5efbaf3