Class II — Klowen Braces
| Recalling firm | KLOwen Braces dba KLOwen Orthodontics |
|---|---|
| Registered facility | KLOWEN BRACES DBA KLOWEN ORTHODONTICS (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A product error defect may cause incorrect bracket placement. |
| Product | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of OH, TX, SC VA. |
| Initiated | 2026-06-08 |
| Classified | 2026-07-08 |
| Recall number | Z-2699-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Klowen Braces (Z-2699-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99277/
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