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.
This recall has been terminated (originally issued October 23, 2012).
- Company
- Ormco/Sybronendo
- Recall Initiated
- April 24, 2012
- Posted
- October 23, 2012
- Terminated
- December 12, 2012
- Recall Number
- Z-0120-2013
- Quantity
- 148
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039
Root Cause
Labeling mix-ups
Action Taken
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.