Events

Recall of Device Recall Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And 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
    28423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0705-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31839
  • 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
    Camera, Still, Endoscopic - Product Code FXM
  • Reason
    Endocouplers assembled with screws that cannot be effectively sterilized.
  • Action
    Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Serial #s: 50001621-2  50001621-1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK
  • Product Description
    Endocoupler C-Mount 35 mmFocal Length || Catalog Number: 6900398
  • Manufacturer
    Smith And Nephew, Inc. Endoscopy Division

Manufacturer

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