Events

Recall of Device Recall Stainless Steel, Natural, Upper, .018": 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
    59110
  • Event Risk Class
    Class 3
  • Event Number
    Z-2729-2011
  • Event Initiated Date
    2008-01-07
  • Event Date Posted
    2011-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101218
  • 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
    Dental Orthodontic Wire - Product Code D ZC
  • Reason
    Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
  • Action
    Highland 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

Device

Device Recall Stainless Steel, Natural, Upper, .018": Arch Wires
  • Model / Serial
    Product number: 20041800, lot number 9321. Product was mislabeld as lower
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide 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.
  • Product Description
    Stainless Steel, Natural, Upper, .018": Arch Wires. || Highland Metals, San Jose, CA 95125
  • Manufacturer
    Highland Metals

Manufacturer

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