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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 not a dental professional and does not have a thorough understanding of the dentistry and orthodontic principles, clinical applications, and risks. - The improper use of poor-quality dental scans as an input for treatment planning. - The lack of knowledge of the tools available for use during collision detection. - The sale of this product to someone other than a dental professional. - The user not knowing that they needed the necessary product training to use the software. - A lack of understand that a failure to observe all warnings and precautions may result in complications. - A lack of knowledge of theoretical adverse events that could result during sequential aligner treatment, after using this software. - A lack of knowledge regarding the technical description of the product. - A lack of knowledge regarding the technical requirements of the system. - Poor fit, possibly resulting in: ++ Poor fit ++ Infection ++ TMD ++ Crown Removal - Inappropriate tooth movements, including: ++ Nerve Damage ++ Pulpal Degradation ++ Gingival Recession ++ Root Resorption ++ Tooth Extrusion ++ Tooth Loss ++ Unintended tooth movement Customer are informed to: 1) Read the document (MKT-LB-005) that is included with the the customer notification. The document includes all information missing from the label sent with the delivery of the product. 2) Send a read receipt associated with the ema