O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth move
Summary
The FDA issued a Class II for O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instru by Orchestrate Orthodontic Technologies, Inc.. Reason: Due to product label/labeling being altered from it's approved state..
Details
Source
Device Recall
External ID
Z-0334-2022
Action Date
2021-12-15
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
Quantity Affected: 127 copies
Reason for Recall
Due to product label/labeling being altered from it's approved state.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-11
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orchestrate Orthodontic Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orchestrate Orthodontic Technologies, Inc. have FDA actions?
This is the only FDA action we have on record for Orchestrate Orthodontic Technologies, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0334-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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