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Class 3 Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. |
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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
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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
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For Additional Information Contact |
Lena Becker 408-271-2955
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Manufacturer Reason for Recall |
Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
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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. |
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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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