FDAFDA · Food and drugs·Recall number Z-0120-2013
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.
Published October 31, 2012 · Recall initiated: April 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ormco/Sybronendo
- Distributor
- 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
- Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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