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U.S. Department of Health and Human Services

Class 2 Device Recall Maestro Orthodontic Bracket

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  Class 2 Device Recall Maestro Orthodontic Bracket see related information
Date Initiated by Firm April 02, 2019
Create Date June 30, 2020
Recall Status1 Terminated 3 on March 24, 2022
Recall Number Z-2477-2020
Recall Event ID 85468
Product Classification Bracket, metal, orthodontic - Product Code EJF
Product Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only
(01)00190707016517 (10)112233 (422)484
Code Information Maestro Orthodontic Bracket REF711-206-10  (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666 
Recalling Firm/
Manufacturer		 Ortho Organizers, Inc.
1822 Aston Ave
Carlsbad CA 92008-7306
For Additional Information Contact Customer Service
760-448-8600
Manufacturer Reason
for Recall		 Orthodontic Bracket is mislabeled
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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