Events

Recall of ConMed Laparoscopic Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Corporation.

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
    36515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0097-2007
  • Event Initiated Date
    2006-10-12
  • Event Date Posted
    2006-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48806
  • 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
    Laparoscopic Instrument - Product Code GCJ
  • Reason
    The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
  • Action
    On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.

Device

ConMed Laparoscopic Instrument
  • Model / Serial
    REF/Product Code 60-6045-002, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Manufacturer Address
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA