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U.S. Department of Health and Human Services

Class 3 Device Recall Stainless Steel, Progressive Lower, .016: Arch Wires

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 Class 3 Device Recall Stainless Steel, Progressive Lower, .016: Arch Wiressee related information
Date Initiated by FirmJanuary 07, 2008
Date PostedJuly 07, 2011
Recall Status1 Terminated 3 on July 07, 2011
Recall NumberZ-2727-2011
Recall Event ID 59110
Product Classification Dental Orthodontic Wire - Product Code D ZC
ProductStainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic treatment
Code Information Product number: 20001601 , lot number 8542. Product was mislabeld as lower   
Recalling Firm/
Manufacturer		 Highland Metals
419 Perrymont Ave
San Jose CA 95125-1445
For Additional Information ContactLena Becker
408-271-2955
Manufacturer Reason
for Recall		Boxes of stainless steel orthodontic wires were mislabeled as size.018"
FDA Determined
Cause 2		Employee error
ActionHighland Metals sent out "Highland Metals Advisory Notice Mislabeld Products Alert" and "Advisory Notice" letters from January 11, 2008 to April 18, 2008 to all affected costumers. The letter included: product name and affected lots. It advised them of the mislabeling and instructed them to return the product for replacement. For additional information contact Highland Metals at (408) 271-2955
Quantity in Commerce22 packs of 100
DistributionWorldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.
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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