Ultradent Recalls Avex CX2 Ceramic Orthodontic Brackets Due to Design Control Issues
Ultradent is recalling 217 units of Avex CX2 Ceramic Orthodontic Brackets because the design control process was not completed before distribution.
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 FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ultradent Products, Inc. is recalling 217 units of Avex CX2 Ceramic Orthodontic Brackets. These brackets are intended for use in orthodontic treatment. The recall was initiated because the design control process was not complete prior to the distribution of the product.
The affected lots include R&D Lot Numbers 4519 through 4522, 4524 through 4527, 4530 through 4534, 4537 through 4548, 4550 through 4554, 4558 through 4612, and 4618 through 4624. The products were distributed nationwide, including in Utah, California, Washington, Virginia, Ohio, and Tennessee.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should contact Ultradent Products, Inc. for further information regarding the recall.
The recalled product
- Product
- Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 217
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 (7)
- R&D Lot Numbers:4519 - 4522
- 4524 - 4527
- 4530 - 4534
- 4537 - 4548
- 4550 - 4554
- 4558 - 4612
- 4618 - 4624
Distribution
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