Ultradent Recalls Mislabelled Avex CX Orthodontic Brackets
Ultradent Products, Inc. is recalling 124 units of Avex CX orthodontic brackets due to incorrect labeling. The affected products were distributed nationwide in the US.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The source text identifies the issue as incorrect labeling without reporting any injuries or illnesses.
Plain-English summary
Ultradent Products, Inc. is recalling 124 units of Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017 orthodontic brackets. The recall was initiated because the distributed products were incorrectly labeled. These ceramic brackets are formed with 99.9% pure alumina oxide and are indicated for the mechanical movement of natural teeth.
The affected units, identified by Lot R131360, were distributed nationwide in the United States, including the states of California, Arizona, Colorado, and Washington. The source text does not specify the exact nature of the labeling error or report any associated illnesses or injuries.
Consumers and healthcare providers who have purchased or received these specific brackets should stop using them and contact Ultradent Products, Inc. for further instructions or a refund.
The recalled product
- Product
- Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed…
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 124
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)
- Lot R131360
Distribution
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