Z-0334-2022Class II

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for...

Name: Z-0334-2022 O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for...
Creator: Orchestrate Orthodontic Technologies, Inc.
Published: 2021-11-11
License: https://open.fda.gov/license/

Orchestrate Orthodontic Technologies, Inc. / initiated 2021-11-11 / Terminated / root cause: manufacturing process

FDA source

Orchestrate Orthodontic Technologies, Inc. began a recall of O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d... on 2021-11-11. FDA classified it as Class II and gives the reason as "Due to product label/labeling being altered from it's approved state". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0334-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-11
Posted: 2021-12-06
Terminated: 2024-01-10
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
Product code: PNN Orthodontic Software
Reason for recall: Due to product label/labeling being altered from it's approved state.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0334-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0334-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-06

Product code PNN

K181112Class IIOrchestrate 3DOrchestrate 3D / cleared 2018-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)