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Incident · Recall

Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command

Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, openFDA enforcement / accessdata.fda.gov.

Occurred 2016-04-08 · Zimmer Biomet · Investigated by FDA

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Track Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command

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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 Surgical Device 2.5.8 over software changing final tool orientation without command?
Zimmer Biomet recalled the ROSA Surgical Device 2.5.8 because the software could change the final tool orientation for the command position without an operator command. 64 units. Source: FDA Class 2 device recall Z-0115-2018, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on April 8, 2016 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 Surgical Device 2.5.8 over software changing final tool orientation without command?
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 Surgical Device 2.5.8 over software changing final tool orientation without command?
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 software changing final tool orientation without command?
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 Surgical Device 2.5.8 over software changing final tool orientation without command.

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Canonical ID 1a04a6d9-fb59-444e-92d8-e01f77c618e3