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Orchestrate Orthodontic Technologies, Inc. Recall 89013

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

Orchestrate Orthodontic Technologies, Inc. Recall 89013 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0334-2022
Event ID89013
Event DescriptionO3D 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 TypeDevices
DistributionWorldwide 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.
Quantity127 copies
Recall ReasonDue to product label/labeling being altered from it's approved state.
Device Classification20211215
Device Code InfoAll versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
Center Classification Date20211206
Recall Initiation Date20211111
Recalling FirmOrchestrate Orthodontic Technologies, Inc.
Initial Notification Letter
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