Events

Rappel de Device Recall ProLite Mesh

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 Atrium Medical Corporation.

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
    79293
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0712-2018
  • Date de mise en oeuvre de l'événement
    2017-11-22
  • Date de publication de l'événement
    2018-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161830
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Cause
    An incorrect prolite mesh configuration was packaged as product code 1010306-06, with lot number 412298. prolite mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
  • Action
    Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at internationalcs@atriummed.com for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed Urgent Medical Device Field Safety Notice to acknowledge receipt. Return the completed form to the following e-mail address: MESH2017@getinge.com For further questions, please call (973) 709-7654.

Device

Device Recall ProLite Mesh
  • Modèle / numéro de série
    Product Code/REF 1010306-06 Lot Number/LOT: 412298
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Internationally to Spain only.
  • Description du dispositif
    ProLite Mesh - mesh, surgical, polymeric || ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Adresse du fabricant
    Atrium Medical Corporation, 40 Continental Blvd, Merrimack NH 03054-4332
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA