Events

Recall of Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc. Endoscopy Division.

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
    52211
  • Event Risk Class
    Class 2
  • Event Number
    Z-2078-2009
  • Event Initiated Date
    2009-05-27
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82536
  • 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
    Arthroscope - Product Code HRX
  • Reason
    The sterility of the device cannot be assured.
  • Action
    Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.

Device

Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked S...
  • Model / Serial
    0169H, 0299J, 0409K, 0409L, 0409M, 0479U, 0479X, 0489F, 0489H, 0859F, 0899J, 0919F, 1618F, 1618L, 1618LR, 1628F, 1628FR, 1648K, 1648KR, 1758J,1838K, 1908M, 1938F, 2058L, 2528F, 2528FR, 2558F, 2698J, 2748F, 2748P, 2808U, 2838L, 2848H, 2878N, 2908U, 2908V, 3038N, 3048M, and 3258P.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
  • Product Description
    DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction || Catalog Number: 7211006
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA