Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets
Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall affects 104 packages distributed to US and international consignees.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text identifies the issue as mislabeling without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Ortho Organizers, Inc. is recalling Maestro Orthodontic Brackets (REF711-206-10) because the product is mislabeled. The recall involves 104 packages of the orthodontic brackets.
The affected products were distributed to 13 US consignees in Florida, Georgia, California, Michigan, Idaho, and Texas, as well as consignees in Italy, Japan, Greece, Saudi Arabia, Russia, and the Czech Republic. The specific lot numbers involved are 898430 and 888666.
Consumers and healthcare providers should stop using the affected brackets and contact Ortho Organizers for further instructions or a refund.
The recalled product
- Product
- Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
- Manufacturer
- Ortho Organizers, Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 104
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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