Home / Recalls / Ormco/Sybronendo / Z-0120-2013

Z-0120-2013 Class III Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
October 31, 2012
Initiation Date
April 24, 2012
Termination Date
December 12, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
148

Product Description

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.

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 Pattern

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.

Code Information

Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039

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