Klowen Braces — Class II: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Klowen Braces has initiated a recall for the KL Owen Custom Orthodontic Solution (model/catalog number CIAS-800033) due to a product error defect that may lead to incorrect bracket placement.
This recall affects Klowen Braces, orthodontic practitioners using the CIAS-800033 system, and clinical staff responsible for the application of custom orthodontic brackets.
The defect suggests a failure in the design or manufacturing precision of the custom solution, which could lead to suboptimal clinical outcomes or the need for corrective orthodontic procedures. For regulatory professionals, this underscores the importance of validating custom-fit device software or manufacturing templates to ensure physical placement matches the intended clinical plan.
QA teams should verify the precision of digital-to-physical placement scripts and ensure that any 'product error defects' are addressed within the CAPA system to prevent recurrence in custom-made components. Providers using this specific catalog number should monitor for bracket misalignment.
Class II. Reason: A product error defect may cause incorrect bracket placement.. Product: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,. Firm: Klowen Braces (Richardson TX United States). Status: Ongoing.
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