Events

Recall of 5mm Pyramidal Trocar

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

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
    50489
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-2009
  • Event Date Posted
    2008-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75491
  • 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
    General & Plastic Surgery Surgical Cannula - Product Code GEA
  • Reason
    The stainless steel tips on the genicon 5mm pyramidal trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.
  • Action
    Consignees were notified with a letter, dated 9/19/2008, by e-mail and fax on 09/25/2008. The letter stated a description of the issue, analysis and reliability data, indications of Device Malfunction, and recommendations. There was also a request for all defective devices to be returned to the distributor or Genicon for replacement. Genicon Customer service was to be contacted at 407-657-4851.

Device

5mm Pyramidal Trocar
  • Model / Serial
    Lot # I1219-K, exp: 11/01/2012; I1220-K, exp: 11/01/2012; I1278-K, exp: 01/01/2013; I1281-K, exp: 01/01/2013; I1393-K, exp: 03/01/2013; I1394-K, exp: 03/01/2013; I1415-K, exp: 03/01/2013; I1423-K, exp: 03/01/2013; I1487-K, exp: 04/01/2013; I1470-K, exp: 04/01/2013; and I1471-K, exp: 04/01/2013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.
  • Product Description
    Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. || Used for incisions made for positioning the laparoscopic cannulas or ports.
  • Manufacturer
    Genico, Inc., dba Genicon

Manufacturer

Genico, Inc., dba Genicon
  • Manufacturer Address
    Genico, Inc., dba Genicon, 6869 Stapoint Ct Ste 114, Winter Park FL 32792-6603
  • Manufacturer Parent Company (2017)
    Genicon Inc
  • Source
    USFDA