Events

Rappel de Device Recall FassierDuval Telescopic IM System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Pega Medical Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54620
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1494-2011
  • Date de mise en oeuvre de l'événement
    2010-01-29
  • Date de publication de l'événement
    2011-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88796
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    orthopedic manual instrument - Product Code HSB
  • Cause
    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
  • Modèle / numéro de série
    Catalog number MDr132L (size 3.2 mm) with Lot Code 270730-01.   Catalog number MDr140L (size 4.0 mm) with Lot Code 270730-02.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Pega Medical Inc., 1105 Autoroute Chomedy, Laval Canada
  • Société-mère du fabricant (2017)
    Pega Medical Inc.
  • Source
    USFDA