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Incident · Recall

Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy

Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because an undetected shift could occur between the navigation-software display and the actual patient anatomy. 21 units. Source: FDA Class 2 device recall Z-0102-2018, openFDA enforcement / accessdata.fda.gov.

Occurred 2014-02-14 · ROSA at France · Zimmer Biomet · France · Surgical robots · Investigated by FDA

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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 Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy

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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=159361

Common questions

What happened in Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy?
Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because an undetected shift could occur between the navigation-software display and the actual patient anatomy. 21 units. Source: FDA Class 2 device recall Z-0102-2018, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on February 14, 2014 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 an undetected shift between navigation display and patient anatomy?
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 an undetected shift between navigation display and patient anatomy?
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 an undetected shift between navigation display and patient anatomy?
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 Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy.

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Canonical ID 73103d94-1bbc-4015-a4b4-ef75c0800606