Class 2 Device Recall Orchestrate 3d Software

• Date Initiated by Firm: November 11, 2021
• Create Date: December 06, 2021
• Recall Status: Terminated on January 10, 2024
• Recall Number: Z-0334-2022
• Recall Event ID: 89013
• 510(K)Number: K181112
• Product Classification: Orthodontic software - Product Code PNN
• 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
• Code Information: All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
• Recalling Firm/ Manufacturer: Orchestrate Orthodontic Technologies, Inc.; 1747 N Riverside Ave; Rialto CA 92376-8062
• For Additional Information Contact: Lauren Stewart; 231-920-0334
• Manufacturer Reason for Recall: Due to product label/labeling being altered from it's approved state.
• FDA Determined 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 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
• Quantity in Commerce: 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, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PNN