Orchestrate Orthodontic Technologies, Inc. recalls O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth move…

Recall date

November 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0334-2022

FDA classification

Class II

Brand / firm

Orchestrate Orthodontic Technologies, Inc.

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. The countries of Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, I…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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