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Orchestrate Orthodontic Technologies, Inc. recalls O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth move
Recalled December 15, 2021 · FDA recall Z-0334-2022 · Orchestrate Orthodontic Technologies
Hazard
Due to product label/labeling being altered from it's approved state. · FDA Class II
Units
127 copies
Sold at
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, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.
Description
Due to product label/labeling being altered from it's approved state.
Product
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
Manufacturer(s)
Orchestrate Orthodontic Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →