Class II — Ortho Organizers, Inc.
| Recalling firm | ORTHO ORGANIZERS , INC. |
|---|---|
| Registered facility | ORTHO ORGANIZERS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Orthodontic Bracket is mislabeled |
| Product | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484 |
| Quantity | 147 kits |
| Distribution | 13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic |
| Initiated | 2019-04-02 |
| Classified | 2020-06-30 |
| Terminated | 2022-03-24 |
| Recall number | Z-2478-2020 |
| 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 — Ortho Organizers, Inc. (Z-2478-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85468/
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