Events

Recall of Device Recall Supporter toilet armrest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Etac Supply Center Ab.

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
    71515
  • Event Risk Class
    Class 2
  • Event Number
    Z-2073-2015
  • Event Initiated Date
    2015-06-15
  • Event Date Posted
    2015-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138056
  • 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
    Adaptor, hygiene - Product Code ILS
  • Reason
    The supporter toilet armrest has two fast nuts fixing the product to the toilet porcelain. the firm has reports of the two fast nuts coming loose and causing the supporter to become unsteady.
  • Action
    Etac sent an Urgent Notice of Field Correction beginning June 15, 2015, to all affected consignees. The letter directed the consignees to do an in field correction with replacement Fast Nuts. Defined replacement instructions were included with the replacement nuts. Customers with questions were instructed to contact their Etac distributor or the Etac coordinator, Snug Seal Inc. at 1-800-336-7683. For questions regarding this recall call 1-800-367-6844.

Device

Device Recall Supporter toilet armrest
  • Model / Serial
    Serial numbers higher than 224017
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including GA, CT and PA.
  • Product Description
    Etac Supporter toilet armrest || Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • Manufacturer Address
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • Manufacturer Parent Company (2017)
    Nordstjernan Ab
  • Source
    USFDA