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U.S. Department of Health and Human Services

Class 2 Device Recall Copper NiTi Preformed Archwires

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  Class 2 Device Recall Copper NiTi Preformed Archwires see related information
Date Initiated by Firm November 04, 2015
Date Posted November 30, 2015
Recall Status1 Terminated 3 on January 19, 2016
Recall Number Z-0343-2016
Recall Event ID 72590
Product Classification Wire, orthodontic - Product Code DZC
Product Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Code Information Lot No. 21538339
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 recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
FDA Determined
Cause 2		 Employee error
Action A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.
Quantity in Commerce 161 units
Distribution Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
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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