Drug recall
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
FDA recall event 85468 · Class II · Ortho Organizers, Inc.
Key facts
| Event ID | 85468 |
|---|---|
| Recall numbers | Z-2477-2020, Z-2478-2020 |
| Recalling firm | Ortho Organizers, Inc. |
| Product type | Devices |
| Products | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484, 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Orthodontic Bracket is mislabeled |
| Initiation date | Apr 2, 2019 |
| Report date | Jul 8, 2020 |
| Termination date | Mar 24, 2022 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 2081322 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: