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FDANovember 11, 2021device

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to product label/labeling being altered from it's approved state.

What to do

FDA enforcement status: Terminated

Brands named

orchestrate orthodontic technologiesorchestrateorchestrate orthodontic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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