Ormco Recalls Bracket Buccal Tubes Due to Packaging Error
Ormco is voluntarily recalling one lot of Bracket Buccal Tubes because the packaging incorrectly identifies the product offset, which may cause unintended tooth rotation.
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 explicitly states that the resulting harm (unintended rotation) is reversible and does not report any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ormco Corporation is voluntarily recalling one lot of Bracket Buccal Tubes (Part Number 438-0184, Lot Number 051063597) due to a packaging error. The product package correctly identifies the product as gingival (0°) offset brackets, but the package actually contains distal (10°) offset brackets.
The affected products are intended to hold orthodontic wires used to move teeth during orthodontic treatment. The use of the affected product may cause unintended rotation of the molars. Although the rotation is reversible, it may result in a delay in treatment.
The recall involves 8,210 units distributed worldwide, including the United States (nationwide) and the European Union. Consumers and healthcare providers should check their inventory for the specific lot number and stop using the affected products if identified.
The recalled product
- Product
- Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Orthodontic
- Affected units
- 8,210
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)
- Part Number 438-0184 Lot Number 051063597
Distribution
Distributed nationwide across the United States.
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