FDA DevicesClass II
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Published: July 15, 2026Recall ID: Z-2699-2026Category: devicesCountry: US
Medical DeviceFDA DevicesUS
USKL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Recalling Firm: Klowen Braces
Reason for Recall / Hazard
A product error defect may cause incorrect bracket placement.
Product Description & Identification
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Additional Source Details
| Field | Value |
|---|---|
| City | Richardson |
| State | TX |
| Event id | 99277 |
| Address 1 | 1900 Firman Dr Ste 800 |
| Address 2 | N/A |
| Code info | UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0 |
| Postal code | 75081-6769 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 3 units |
| Reason for recall | A product error defect may cause incorrect bracket placement. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260608 |
| Initial firm notification | Telephone |
| Center classification date | 20260708 |
Overview
- Recalling FirmKlowen Braces
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of OH, TX, SC VA.
Recall Hazard Severity
Official Agency AlertHigh Alert (Class I)
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🚨 SAFETY ALERT: Klowen Braces - KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, Check if your household is affected: https://therecallfile.com/recalls/kl-owen-custom-orthodontic-solution-model-catalog-number-cias-800033/FDA-Z-2699-2026
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