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U.S. Department of Health and Human Services

Class 3 Device Recall Spirit MB Brackets

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  Class 3 Device Recall Spirit MB Brackets see related information
Date Initiated by Firm May 18, 2011
Date Posted November 16, 2011
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0200-2012
Recall Event ID 60118
510(K)Number K943245  
Product Classification Bracket, plastic, orthodontic - Product Code DYW
Product Spirit MB Brackets, part #494-1210.

The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Code Information Lot #02112284
Recalling Firm/
Manufacturer		 Ormco Corporation
1332 S Lone Hill Ave
Glendora CA 91740
For Additional Information Contact
909-962-5600
Manufacturer Reason
for Recall		 Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
FDA Determined
Cause 2		 Device Design
Action Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.
Quantity in Commerce 10 packs
Distribution Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DYW and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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