Maestro recallZ-2478-2020 · Ortho Organizers, Inc. · initiated Apr 2, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Organizers, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Orthodontic Bracket is mislabeled
FDA root cause category: Process control
What the company is doing
The firm notified their consignees of the recall by letter sent out 1st class mail on 4/2/2019. The recall was initiated due to a mislabeling error. The Upper Right bracket was erroneously color coded as an Upper Left brackets and then comingled within the same bag. The firm is asking recipients of affected product to please contact Customer Service at 1-800-547-2000 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. The firm is requesting that distributors and physicians complete and E-mail the acknowledgment form back to the firm in order to confirm receipt of the field correction letter. Additionally they are asking authorized distributor,to identify those customers that may have been shipped the affected product and contact those customers to inform them of the issue within fortyeight (48) hours of receipt of this field correction notification.
Recall details
- Recall number
- Z-2478-2020
- Status
- Terminated
- Initiated by the company
- Apr 2, 2019
- Recalling firm
- Ortho Organizers, Inc.
- Quantity
- 147 kits
- Product code
- EJF
- 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
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Maestro 711-298QOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 recall0 reports
- Maestro 711-299MCQOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 85468).
- Z-2477-2020 · TerminatedMaestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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