Events

Recall of TRIVEX

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
    37614
  • Event Risk Class
    Class 3
  • Event Number
    Z-1105-2007
  • Event Initiated Date
    2004-10-12
  • Event Date Posted
    2007-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51066
  • 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
    Pneumatic Footswitch - Product Code DWQ
  • Reason
    Build-up of static charge in pneumatic footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
  • Action
    Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.

Device

TRIVEX
  • Model / Serial
    Pnuematic Footswitch part of TRIVEX System with the following serial numbers: 105, 106, 108, 109, 111 -123, 125 - 182, 184 - 188, 192 - 197, 199 - 203, 205 - 219, 222 - 249, 252 - 254, and 7210386.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
  • Product Description
    Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
  • Manufacturer
    Smith & Nephew, Inc Endoscopy Division

Manufacturer

Smith & Nephew, Inc Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc Endoscopy Division, 76 S. Meridian Ave, Oklahoma City OK 73107-6512
  • Source
    USFDA