Events

Recall of Smith & Nephew

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

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
    32160
  • Event Risk Class
    Class 3
  • Event Number
    Z-0973-05
  • Event Initiated Date
    2005-04-06
  • Event Date Posted
    2005-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39275
  • 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
    Clamp, Surgical, General & Plastic Surgery - Product Code GDJ
  • Reason
    Cupped grasper handle marked incorrectly as duckbill upbiter.
  • Action
    Smith & Nephew Endoscopy notified users by letter dated 4/6/05. Accounts are requested to return product.

Device

Smith & Nephew

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • Manufacturer Address
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048-1145
  • Source
    USFDA