Events

Recall of Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.

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

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
    67378
  • Event Risk Class
    Class 2
  • Event Number
    Z-0923-2014
  • Event Initiated Date
    2013-12-13
  • Event Date Posted
    2014-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125381
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wire, orthodontic - Product Code DZC
  • Reason
    Labeling issue: product labeled as "upper" may contain "lower" archwires with a red midline mark. product labeled ad "lower" may contain "upper" archwires with a black midline mark.
  • Action
    Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.

Device

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.
  • Model / Serial
    Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • Product Description
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.14 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.

Manufacturer

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