Events

Recall of Device Recall AES50S

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
    71518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0205-2016
  • Event Initiated Date
    2015-06-17
  • Event Date Posted
    2015-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138104
  • 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
    Probe programming error. the incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
  • Action
    On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions can call Gregory Connell at 727-399-5276 or email AES50S@conmed.com. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.

Device

Device Recall AES50S
  • Model / Serial
    1412161, 1410201, 1410271, 1412121, and 1412081
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US distribution in the states of FL, OH, and the country of Spain.
  • Product Description
    Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S || Peoduct Usage: || For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA