Date Initiated by Firm |
March 08, 2013 |
Date Posted |
April 10, 2013 |
Recall Status1 |
Terminated 3 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 CA 91740-5339
|
For Additional Information Contact |
909-962-5600
|
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 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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