Events

Recall of Device Recall dissector PlasmaKnife (DPK)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus ACMI 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
    49554
  • Event Risk Class
    Class 2
  • Event Number
    Z-0273-2009
  • Event Initiated Date
    2008-10-01
  • Event Date Posted
    2008-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73796
  • 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
    Sterility may be compromised.
  • Action
    Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.

Device

Device Recall dissector PlasmaKnife (DPK)
  • Model / Serial
    Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
  • Product Description
    Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) || Catalog No: 7035-3005 || A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.
  • Manufacturer
    Gyrus ACMI Corporation

Manufacturer

Gyrus ACMI Corporation
  • Manufacturer Address
    Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA