FDA Medical Device Recalls (openFDA)
Ortho Organizers, Inc.: Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
- Recall number
- Z-2477-2020
- Recalling firm
- Ortho Organizers, Inc.
- Product
- Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
- Status
- Terminated
- Initiated
- 2019-04-02
- Posted
- not on file
- Terminated
- 2022-03-24
- Reason
- Orthodontic Bracket is mislabeled
- 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
- 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
- Lot, serial or model codes
- Maestro Orthodontic Bracket REF711-206-10 (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJF
- Firm FEI
- 2081322
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28