Braces Recall: Klowen CIAS-800033
FDA announced a recall of the KL Owen Custom Orthodontic Solution, model CIAS-800033, due to a product error defect that may cause incorrect bracket placement. Three units were distributed nationwide across Ohio, Texas, South Carolina, and Virginia. The recall references UDI/DI 10850061082029 and lot numbers 1779407586392-0, 1779138889952-0, 1778173992342-0; no corrective action is provided.
| Brand | Klowen Braces |
|---|---|
| Product | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, |
| Reason | A product error defect may cause incorrect bracket placement. |
| Severity | moderate |
| Units affected | 3 |
| Distribution | US Nationwide distribution in the states of OH, TX, SC VA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you own this device, stop using it and consult your orthodontist or supplier for guidance.
- Check your device's UDI/DI and lot numbers against the recall numbers to determine if your unit is affected.
- Contact the seller or manufacturer for replacement, return, or disposal instructions.
How to identify the recalled item
| Lot / date codes | UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0 |
|---|---|
| Lot / date codes | UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.