Events

Recall of Device Recall FlexTrayTM Endopath Cholecsystectomy Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery.

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
    30727
  • Event Risk Class
    Class 2
  • Event Number
    Z-0755-05
  • Event Initiated Date
    2004-12-15
  • Event Date Posted
    2005-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36863
  • 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
    Instrument, Manual, Surgical, General Use - Product Code MDM
  • Reason
    Due to tolerance issues with the device, pins can work free from their respective holes. the result during use could be separation of the handles that could lead to compromised ratchet button functionality. loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
  • Action
    The recalling firm sent letters to hospitals and distributors, dated 12/14/04.

Device

Device Recall FlexTrayTM Endopath Cholecsystectomy Tray
  • Model / Serial
    V41X3K.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The devices were distributed to hospitals and distributors located throughout the United States and to foreign consignees located in Saudi Arabia, Austria, Egypt, United Kingdom, Germany, France, Lebanon, The Netherlands, Spain, Pakistan, South Africa, Italy, United Arab Emirate, Czech Republic, Sweden, Switzerland, Greece, India, Portugal, Slovenia, Hungary, Palestine, and Kuwait.
  • Product Description
    FlexTrayTM Endopath¿ Cholecsystectomy Tray, Kit Code TNC69.
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • Manufacturer Address
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Source
    USFDA