Events

Rappel de Device Recall AMS InteXen LP Collagen Dermal Matrix

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 American Medical Systems.

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
    50680
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0932-2009
  • Date de mise en oeuvre de l'événement
    2008-12-05
  • Date de publication de l'événement
    2009-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75984
  • 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
    Surgical Mesh - Product Code FTM
  • Cause
    The product size shown on the carton labeling does not match the size on the product inside.
  • Action
    Customers were first notified by phone on 12/05/08. They were told of the situation and were requested to return the devices. Customers were also provided an Important Product Recall letter, dated 12/05/08. This letter identified affected product, told customers to discontinue use of product and to return it. An acknowledgement form was also asked to be returned. AMS Customer Service should be contacted at 1-800-328-3881 to receive a Return Authorization number and arrange for shipment of replacement product.

Device

Device Recall AMS InteXen LP Collagen Dermal Matrix
  • Modèle / numéro de série
    lot/serial number: 567398002, 567398003
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution --- including states of TN and TX.
  • Description du dispositif
    AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. || The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Adresse du fabricant
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA