Events

Recall of Device Recall ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Linvatec Corp..

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
    33326
  • Event Risk Class
    Class 2
  • Event Number
    Z-1444-06
  • Event Initiated Date
    2005-08-30
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41702
  • 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
    footswitch - Product Code GEY
  • Reason
    The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting.
  • Action
    Linvatec has issued recall notification to all it''s direct accounts. The mailings were sent by UPS 08/31/2005. Each consignee was requested to return the affected product to Linvatec for a free replacement footswitch.

Device

Device Recall ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch
  • Model / Serial
    Serial numbers BBB81339-BBB81407, BBB91192-BBB91194, BBBB91209-BBB91366 and BBB91664-BBB91672.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including United States and Canada.
  • Product Description
    ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Manufacturer Address
    Linvatec Corp., 11311 Concept Blvd, Largo FL 33773-4908
  • Source
    USFDA