Events

Recall of 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
    71061
  • Event Risk Class
    Class 2
  • Event Number
    Z-1546-2015
  • Event Initiated Date
    2015-04-10
  • Event Date Posted
    2015-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135963
  • 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 hexagonal tip of the female driver instrument for the fassier-duval im telescopic system is 0.06 mm under the specifications. this may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
  • Action
    The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com

Device

FassierDuval IM Telescopic System
  • Model / Serial
    Lot 290609-01
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
  • Product Description
    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. || This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
  • 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