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U.S. Department of Health and Human Services

Class 2 Device Recall Bracket Buccal Tube

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 Class 2 Recall
Bracket Buccal Tube
see related information
Date Posted April 10, 2013
Recall Status1 Terminated on September 04, 2013
Recall Number Z-1084-2013
Recall Event ID 64749
Product Classification Tube, Orthodontic - Product Code DZD
Product Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Code Information Part Number 438-0184 Lot Number 051063597
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora, California 91740-5339
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0¿) offset brackets, but actually contains distal (10¿) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Ormco sent an Urgent Medical Device Recall letter dated March 8, 2013 to all affected customers, via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees were instructed to complete the Return Form and return any affected product identified in stock. For questions contact Ormco Customer Care.
Quantity in Commerce 8210
Distribution Worldwide Distribution - USA (nationwide) including the country of EU.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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