CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Maestro Orthodontic Bracket REF711-298Q QTY recalled by Ortho Organizers
Ortho Organizers is recalling Maestro Orthodontic Bracket REF711-298Q QTY, distributed in California, Florida, Georgia, Idaho, Michigan, Texas. The recall was initiated on 2 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2478-2020
- FDA event ID
- 85468
- Recalling firm
- Ortho Organizers, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2019
- FDA classified
- 30 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Dental Devices
Timeline
| 2 Apr 2019 | Recall initiated by company | |
| 30 Jun 2020 | Classified by FDA | +455 days |
| 8 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Orthodontic Bracket is mislabeled
Product as listed by the FDA
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
Where it was distributed
13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic
Questions about this recall
Is Maestro Orthodontic Bracket REF711-298Q QTY recalled?
Yes. Ortho Organizers recalled Maestro Orthodontic Bracket REF711-298Q QTY on 2 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-2478-2020.
Why was it recalled?
Orthodontic Bracket is mislabeled
Which lots are affected?
Maestro Orthodontic Bracket ,.018 Kit U/L SxS P/N711-298Q (01)00190707017064 (10)889437 (422)484 Lot# 878285 Maestro Orthodontic Bracket .018 Kit U/L SxS MC Hooks P/N711-299MCQ UDI (01)00190707017071(10)889437 (422)484 Lot#872900
Where was it sold?
13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho Organizers
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Maestro Orthodontic Bracket REF711-206-10 QTY recalled | Ortho Organizers | Labeling Errors | 6 states |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |