U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Tube, orthodontic - Product Code DZD
원인
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.
조치
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.
Worldwide Distribution - USA (nationwide) including the country of EU.
제품 설명
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