Events

Recall of Device Recall NDO Surgical Plicator EPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NDO Surgical, 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
    37247
  • Event Risk Class
    Class 2
  • Event Number
    Z-0685-2007
  • Event Initiated Date
    2007-01-26
  • Event Date Posted
    2007-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50185
  • 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
    Endoscope - Product Code KOG
  • Reason
    Device arm may fail to open after being deployed and require surgical intervention to remove.
  • Action
    NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.

Device

Device Recall NDO Surgical Plicator EPS
  • Model / Serial
    Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.
  • Product Description
    Plicator EPS Plication System || Catalog Number: 160-01128R
  • Manufacturer
    NDO Surgical, Inc.

Manufacturer

NDO Surgical, Inc.
  • Manufacturer Address
    NDO Surgical, Inc., 125 High St Ste 7, Mansfield MA 02048-2165
  • Source
    USFDA