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U.S. Department of Health and Human Services

Class 3 Device Recall Damon 3MX Bicuspid Bracket

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  Class 3 Device Recall Damon 3MX Bicuspid Bracket see related information
Date Initiated by Firm April 24, 2012
Date Posted October 23, 2012
Recall Status1 Terminated 3 on December 12, 2012
Recall Number Z-0120-2013
Recall Event ID 63296
Product Classification Bracket, metal, orthodontic - Product Code EJF
Product The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039

Product Usage:
Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Code Information Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039      
Recalling Firm/
Manufacturer		 Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora CA 91740-5339
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall		 The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.
FDA Determined
Cause 2		 Labeling mix-ups
Action Ormco/Sybronendo sent an Urgent Medical Device Recall letter via USPS 1~1 class mail, on April 24, 2012 to all consignees. Consignees were sent an updated customer notification via USPS lSI class mail on June 28, 2012. The letters identified the affected product, problem and actions to be taken. Consignees were instructed to complete the Acknowledgement/Return Form and to return any affected product in their inventory. Customers were instructed to contact Ormco Customer Care at 1-800-854-1741 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
Quantity in Commerce 148
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.
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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