Events

Recall of ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.

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
    29478
  • Event Risk Class
    Class 2
  • Event Number
    Z-1301-04
  • Event Initiated Date
    2004-06-28
  • Event Date Posted
    2004-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33813
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. there is potential for electrical shock.
  • Action
    Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.

Device

ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 -...
  • Model / Serial
    Cat. #60-5158-034 with lot #s 0310301, 0402031, 0403051, 0404131;  Cat. # 60-5158-234 with lot # 0310081;  Cat. #60-5158-432 with lot #s 0310081, 0310301, 0311101, 0401051, 0401121, 0402031, 0403051, 0411121;  Cat. # 60-5158-934 with lot #s 0311101, 0401121.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
  • Product Description
    ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
  • Manufacturer
    Conmed Corporation

Manufacturer

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