Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
This recall has been terminated (originally issued April 2, 2019).
- Company
- Ortho Organizers, Inc.
- Recall Initiated
- April 2, 2019
- Terminated
- March 24, 2022
- Recall Number
- Z-2477-2020
- Quantity
- 104 packages
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Orthodontic Bracket is mislabeled
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 / Code Info
Maestro Orthodontic Bracket REF711-206-10 (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666
Root Cause
Process control
Action Taken
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.