Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Highland Metals.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59349
  • Event Risk Class
    Class 3
  • Event Number
    Z-2963-2011
  • Event Initiated Date
    2011-07-12
  • Event Date Posted
    2011-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102341
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Orthodontic Wire - Product Code D ZC
  • Reason
    Heat activated niti, natural, upper, .019 x 25" arch wires mixed with size 021x0.25" arch wires.
  • 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.

Device

Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.
  • Model / Serial
    Model: 001. P/N: 11219251124; Lot # 34415.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
  • Product Description
    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.
  • Manufacturer
    Highland Metals

Manufacturer

Highland Metals
  • Manufacturer Address
    Highland Metals, 419 Perrymont Ave, San Jose CA 95125-1445
  • Source
    USFDA