Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets
Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall involves 147 kits distributed to US and international consignees.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho Organizers, Inc. is recalling Maestro Orthodontic Brackets, specifically the REF711-298Q and REF711-299MCQ models, due to mislabeling. The recall covers 147 kits of the product.
The affected products were distributed to 13 consignees in the United States, located in Florida, Georgia, California, Michigan, Idaho, and Texas. Additionally, the products were distributed to one consignee each in Italy, Japan, Greece, Saudi Arabia, Russia, and the Czech Republic.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected brackets and contact Ortho Organizers for instructions on how to return the product.
The recalled product
- Product
- Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
- Manufacturer
- Ortho Organizers, Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 147
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Maestro Orthodontic Bracket
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho Organizers, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ortho Organizers, Inc.
See all →- ModerateOrtho Organizers Recalls Mislabeled Maestro Orthodontic Brackets
FDA (Devices) · 2020-07-08
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