O3D ORCHESTRATE Orthodontic Technologies User Manual recall: Labeling Error
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for…
Why was O3D ORCHESTRATE Orthodontic Technologies User Manual recalled?
Due to product label/labeling being altered from it's approved state.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
- Product
- O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for…
- Recalling firm
- Orchestrate Orthodontic Technologies, Inc.
- 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.
- Recall date
- December 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)