Events

Recall of Device Recall MC5057 Universal Cable, 12 ft (3.6 meters)

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

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
    52812
  • Event Risk Class
    Class 1
  • Event Number
    Z-2007-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84057
  • 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
    Universal Cable - Product Code HWE
  • Reason
    Sufficiently worn/damaged universal cable with product number mc5057, when used with various conmed linvatec electric handpieces, may cause the handpiece to self activate.
  • Action
    ConMed Linvatec notified customers via letter, cautioning the users to inspect cords for signs of excessive wear or damage and urging them to discontinue use and return cables when appropriate. Direct questions to Linvatec Corporation by calling 1-800-237-0169.

Device

Device Recall MC5057 Universal Cable, 12 ft (3.6 meters)
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including United States.
  • Product Description
    MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. || ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. || The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Manufacturer Address
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA