Events

Recall of Device Recall FassierDuval Telescopic IM 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
    54620
  • Event Risk Class
    Class 2
  • Event Number
    Z-1494-2011
  • Event Initiated Date
    2010-01-29
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88796
  • 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
    orthopedic manual instrument - Product Code HSB
  • Reason
    Possible breakage. structural weakness has been detected on the male driver 3.2mm and 4.0mm sizes. in certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.
  • Action
    On 01/29/2010, Pega Medical began contacting their consignees by e-mail and telephone. Pega Medical followed up with their consignees by sending out the replacement components along with the explanation letter. The subject on the letter is Notice for 3.2 mm and 4.0 mm Male Drivers of the Fassier-Duval IM Telescopic System. The consignees were informed that there could be a structural weakness in some of the Male Driver instruments. This problem has been detected on the 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. Consignees can contact Pega Medical at 450-688-5144 x 242.

Device

Device Recall FassierDuval Telescopic IM System
  • Model / Serial
    Catalog number MDr132L (size 3.2 mm) with Lot Code 270730-01.   Catalog number MDr140L (size 4.0 mm) with Lot Code 270730-02.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
  • Product Description
    Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.
  • Manufacturer
    Pega Medical Inc.

Manufacturer

Pega Medical Inc.
  • Manufacturer Address
    Pega Medical Inc., 1105 Autoroute Chomedy, Laval Canada
  • Manufacturer Parent Company (2017)
    Pega Medical Inc.
  • Source
    USFDA