Events

Recall of Device Recall Armstrong Grommet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Summit Medical, 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
    68267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1731-2014
  • Event Initiated Date
    2014-05-12
  • Event Date Posted
    2014-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127240
  • 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
    Tube, tympanostomy - Product Code ETD
  • Reason
    One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. this poses no health hazard to the user or patient.
  • Action
    Consignees was sent a Summit Medical "Medical Device Recall" letter, dated May 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to examine their inventory and to quarantine the product. Consignees need to immediately examine their inventory quarantine any affected product. Also, they are to complete and return the "Recall Response Form." For questions they can contact Nicole Dove at (651) 789-3921 or ndove@summitmedicalusa.com.

Device

Device Recall Armstrong Grommet
  • Model / Serial
    Lot #: 147809
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including CA, and GERMANY.
  • Product Description
    Armstrong Grommet with wire Otological Ventilation Tube || Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. || Intended to provide ventilation to the middle ear space through the tympanic membrane.
  • Manufacturer
    Summit Medical, Inc.

Manufacturer

Summit Medical, Inc.
  • Manufacturer Address
    Summit Medical, Inc., 815 Northwest Pkwy Ste 100, Eagan MN 55121-1658
  • Source
    USFDA