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Regulatory filing

fda_recall (us_fda)

Class I recall of the Zimmer Biomet ROSA ONE Brain 3.1 where software could drive the arm along an unintended trajectory; 2021.

fda recall · recalled · decided 2021-10-29


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda recall
Status
recalled
Filing date
2021-09-22
Decision date
2021-10-29
Verification posture
verified

Applicant

Zimmer Biomet

Covered models (1)

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

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Identity

c08e6b1f-f559-40f6-bd97-39c7fc610ef9