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Ormco/Sybronendo recalls The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -
Recalled October 31, 2012 · FDA recall Z-0120-2013 · Ormco/Sybronendo
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. · FDA Class III
Units
148
Sold at
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.
Description
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.
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.
Manufacturer(s)
Ormco/Sybronendo
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →