KL Owen Custom Orthodontic Solution bracket placement defect
Klowen Braces is recalling 3 units of the KL Owen Custom Orthodontic Solution (model CIAS-800033) due to a product error that may cause incorrect bracket placement.
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: This is an FDA Class II recall with a product defect (incorrect bracket placement) that could affect orthodontic treatment. The source text does not report any injuries or illnesses, so per the rubric this qualifies as Moderate rather than Severe.
Plain-English summary
Klowen Braces is recalling the KL Owen Custom Orthodontic Solution, model CIAS-800033, distributed nationwide in Ohio, Texas, South Carolina, and Virginia. A product error defect may cause incorrect bracket placement.
Affected units have UDI/DI 10850061082029 and lot numbers 1779407586392-0, 1779138889952-0, or 1778173992342-0. Consumers who have received this orthodontic product should contact their orthodontist or Klowen Braces to determine if their device is affected and for guidance on appropriate steps.
This is a Class II recall. For additional information, consumers may contact the FDA at the recall reference number Z-2699-2026.
The recalled product
- Product
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Manufacturer
- Klowen Braces
- Category
- Medical Device — Orthodontic
- Affected units
- 3
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 (4)
- UDI/DI 10850061082029
- Lot Numbers: 1779407586392-0
- 1779138889952-0
- 1778173992342-0
Distribution
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