Orchestrate Orthodontic Technologies, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0334-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 11, 2021

Date Posted: December 15, 2021

Recall Number: Z-0334-2022

Event ID: 89013

Reason for Recall:

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

Status: Terminated

Product Quantity: 127 copies

Code Information:

All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated