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Klowen Custom Orthodontic Solution
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MEDICAL DEVICE RECALLMODERATE

Klowen Custom Orthodontic Solution

Klowen is recalling the Custom Orthodontic Solution, model CIAS-800033, due to a defect that may cause incorrect bracket placement.

What to do

Stop using the affected orthodontic solution and contact the company for further instructions.

Recalled
Listed
Updated
Recall No.
Z-2699-2026
Agency
FDA
Firm
Klowen Braces
Recall ID
99277
Status
ONGOING

Recall at a glance

Quantity recalled
3 units

Why it was recalled

Klowen is recalling the Custom Orthodontic Solution due to a product error that may cause incorrect bracket placement. The affected model is CIAS-800033.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Lot code
1779407586392-0, 1779138889952-0, 1778173992342-0
UDI-DI
10850061082029, 1779407586392, 1779138889952, 1778173992342

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification