Events

Rappel de Disposable Sterile Consumables for PULSAVAC II

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Zimmer SAS.

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
  • Date
    2008-02-18
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-consommables-steriles-a-usage-unique-pour-systemes-pulsavac-ii-et-pulsavac-iii-societe-zimmer-sas
  • Notes / Alertes
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notes supplémentaires dans les données
  • Action
    On 14/02/2008, as a precautionary measure, Zimmer SAS has withdrawn from the market all the batches of the references contained in the attached message of the medical devices known as Disposable Sterile Consumables for PULSAVAC II and PULSAVAC III Systems, manufactured by Zimmer Orthopedic Surgical Products, following the presence of silicone stains on the packaging of products manufactured between January 1, 2003 and January 7, 2007. According to the manufacturer, these stains, which do not affect the sterility of the products, may be considered damage to the packaging. The company Zimmer SAS has directly notified the recipients of the incriminated lots with the message attached (14/02/2008) (42 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Disposable Sterile Consumables for PULSAVAC II
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    Zimmer SAS

Manufacturer

Zimmer SAS
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    LAANSM