Z-2477-2020Class II

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

Name: Z-2477-2020 Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Creator: Ortho Organizers, Inc.
Published: 2019-04-02
License: https://open.fda.gov/license/

Ortho Organizers Inc / initiated 2019-04-02 / Terminated / root cause: manufacturing process

FDA source

Ortho Organizers, Inc. began a recall of Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484 on 2019-04-02. FDA classified it as Class II and gives the reason as "Orthodontic Bracket is mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2477-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-02
Posted: 2020-06-30
Terminated: 2022-03-24
Recalling firm: Ortho Organizers Inc
Product: Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: Orthodontic Bracket is mislabeled
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 104 packages
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 codes and lots: Maestro Orthodontic Bracket REF711-206-10 (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2477-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2477-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-30
Z-2478-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-30

Product code EJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)