Orchestrate Orthodontic Technologies, Inc. Recall 89013
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
Orchestrate Orthodontic Technologies, Inc. Recall 89013 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0334-2022 |
| Event ID | 89013 |
| Event 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 Type | Devices |
| Distribution | 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. |
| Quantity | 127 copies |
| Recall Reason | Due to product label/labeling being altered from it's approved state. |
| Device Classification | 20211215 |
| Device Code Info | All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1 |
| Center Classification Date | 20211206 |
| Recall Initiation Date | 20211111 |
| Recalling Firm | Orchestrate Orthodontic Technologies, Inc. |
| Initial Notification | Letter |
| Similar To |