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.
What this means for you
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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