Events

Recall of Device Recall Herbst Universal Nut

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Specialty Appliance Works, 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
    70787
  • Event Risk Class
    Class 2
  • Event Number
    Z-1510-2015
  • Event Initiated Date
    2015-03-09
  • Event Date Posted
    2015-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135039
  • 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
    Clamp, wire, orthodontic - Product Code ECN
  • Reason
    The universal nut, a component of the orthodontic herbst appliance was made with 416 ss and not the specified 303 ss.
  • Action
    Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.

Device

Device Recall Herbst Universal Nut
  • Model / Serial
    Product No. 91695 and 91696
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
  • Product Description
    Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
  • Manufacturer
    Specialty Appliance Works, Inc.

Manufacturer

Specialty Appliance Works, Inc.
  • Manufacturer Address
    Specialty Appliance Works, Inc., 4905 Hammond Industrial Dr, Cumming GA 30041-3914
  • Manufacturer Parent Company (2017)
    Specialty Appliance Works, Inc.
  • Source
    USFDA