Events

Recall of Device Recall FassierDuval IM Telescopic System

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

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
    67803
  • Event Risk Class
    Class 2
  • Event Number
    Z-1472-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126357
  • 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
    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES - Product Code HSB
  • Reason
    The outer package label contained the incorrect length of the device. there is a label on the outer package and an additional label on the product contained in the package.
  • Action
    There is an error on the outside label of the implant. The length was mistaken on the label. It was indicated 245mm instead of 338mm. It has to be clarified that the Fassier-Duval implant is provided with two labels, one that is outside the tube used for packaging and one inside the tube.

Device

Device Recall FassierDuval IM Telescopic System
  • Model / Serial
    Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13  111019-01 and 110808-13  110302-01 and 110808-13
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
  • Product Description
    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. || -Duval IM Telescopic System.
  • Manufacturer
    Pega Medical Inc.

Manufacturer

Pega Medical Inc.
  • Manufacturer Address
    Pega Medical Inc., 1111 Autoroute Chomedy, Laval Canada
  • Manufacturer Parent Company (2017)
    Pega Medical Inc.
  • Source
    USFDA