Recall Z-2699-2026 ยท QJJ Indirect Bonding Tray
Klowen Braces
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
| Date | Jul 8, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | A product error defect may cause incorrect bracket placement. |
| Root cause | Process control |
| Action | KLOwen Orthodontics initially notified their consignees of the recall via telephone on 6/8/2026 and followed with a letter send certified mail on 6/16/2026. The notice explained the issue, potential risk which would arise from the use of the affected product and requested the following: "REQUIRED ACTIONS FOR YOUR PRACTICE 1 Assess the impact. Please review your inventory immediately to identify the affected KLOwen IDB trays and execute the following steps for unused trays. 2 Discard the affected tray to KLOwen. Do not proceed with bonding with the affected tray. Remove the tray from the |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of OH, TX, SC VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.