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U.S. Department of Health and Human Services

Class 2 Device Recall TMA Archwires

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  Class 2 Device Recall TMA Archwires see related information
Date Initiated by Firm March 15, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-0639-2012
Recall Event ID 60582
Product Classification Wire, orthodontic - Product Code DZC
Product TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
Code Information Part Number: 211-1402; Lot Number: 10K291
Recalling Firm/
Manufacturer		 Ormco Corporation
1332 S Lone Hill Ave
Glendora CA 91740
For Additional Information Contact
909-962-5600
Manufacturer Reason
for Recall		 The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
FDA Determined
Cause 2		 Packaging
Action Ormco Corporation sent a Urgent Medical Device Recall letter dated April 29, 2011, to the customers in the United States and Canada via USPS First Class mail. The recall letter for customers in Europe are being translated. Ormco Corporation sent the recall letter dated May 20, 2011, to the customers in Austrailia. The letter identified the product the problem and the action needed to be taken by the customer. As a result of this situation the customer is instructed to return the affected lot number of product. This will be replaced at no charge or credited to account. Please label your returned product " RECALLED PRODUCT" attention Customer Return. In addition, we ask for your assistance in completing the RETURN FORM and returning it by fax 909-962-5605.
Quantity in Commerce 23 Packs
Distribution Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.
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.
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