Recall Z-0334-2022 ยท PNN Orthodontic Software
Orchestrate Orthodontic Technologies, Inc.
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
| Date | Nov 11, 2021 |
| Status | Terminated |
| Reason | Due to product label/labeling being altered from it's approved state. |
| Root cause | Process control |
| Action | On 11/11/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" notification letter to customers informing them they discovered that the labeling sent to customers were not the approved version of the product labeling. The labeling was missing the following items; warnings, cautions, precautions, anticipated adverse events, indication for use, contraindications, software overview and software description. The incorrect labeling could result in the following risks/hazards/harms: - A lack of understanding of the Indications for Use of this software. - Use of the software by someone who is |
| Quantity | 127 copies |
| 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, Ir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181112 | Orchestrate 3D Orchestrate 3D, Nov 26, 2018 |