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 number

Z-0334-2022

Recalling firm

Orchestrate Orthodontic Technologies, Inc.

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

Status

Terminated

Initiated

2021-11-11

Posted

not on file

Terminated

2024-01-10

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 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

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.

Lot, serial or model codes

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

510(k) numbers

["K181112"]

PMA numbers

not on file

Product code

PNN

Firm FEI

3011272616

Firm city

Rialto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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