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U.S. Department of Health and Human Services

Class 2 Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.

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  Class 2 Device Recall SuperElastic Regular force NiTi lower or upper Natural arches. see related information
Date Initiated by Firm December 13, 2013
Date Posted February 03, 2014
Recall Status1 Terminated 3 on February 04, 2014
Recall Number Z-0922-2014
Recall Event ID 67378
Product Classification Wire, orthodontic - Product Code DZC
Product SuperElastic Regular force NiTi lower or upper Natural arches.
0.16 size
10 or 100 count packages.
Highland Metals Inc.
San Jose, CA

The devices are intended to provide force to the teeth to effect movement in order to alter their position.
Code Information Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper 
Recalling Firm/
Manufacturer		 Highland Metals, Inc.
419 Perrymont Ave
San Jose CA 95125-1445
For Additional Information Contact Eveline Carr
408-271-2955
Manufacturer Reason
for Recall		 Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
FDA Determined
Cause 2		 Employee error
Action Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.
Quantity in Commerce 9 packages of each lot number.
Distribution Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
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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