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U.S. Department of Health and Human Services

Class 3 Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.

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  Class 3 Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. see related information
Date Initiated by Firm July 12, 2011
Date Posted August 09, 2011
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-2963-2011
Recall Event ID 59349
Product Classification Orthodontic Wire - Product Code D ZC
Product Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.
Packaged in 19 packages of 100 and 6 packages of 10.
Highland Metals, Inc.

Wire used for orthodontic treatment to place in the brackets to shape teeth.
Code Information Model: 001. P/N: 11219251124; Lot # 34415.
Recalling Firm/
Manufacturer		 Highland Metals
419 Perrymont Ave
San Jose CA 95125-1445
For Additional Information Contact Lena Becker
408-271-2955
Manufacturer Reason
for Recall		 Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Highland Metals, Inc. notified their affected customers by e-mail and followed with an "Important Alert" letter dated July 12, 2011. The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued. For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.
Quantity in Commerce 10 packages of 100
Distribution Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
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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