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.
FDA Recall Z-2963-2011 · Posted 2011-08-09
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Recalling FirmHighland Metals
Recall StatusTerminated
Product CodeD
Date Initiated2011-07-12
Date Terminated2011-09-14
Product Quantity10 packages of 100
Reason for Recall
Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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