Events

Rappel de Implants for knee and hip prosthesis

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 Biomet France.

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
    2011-03-21
  • 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/implants-pour-prothese-de-genou-et-de-hanche-biomet-france-retrait-de-lots
  • 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    On 18/03/2011, the company BIOMET France has withdrawn from the market the batches of medical devices intended for the knee and hip prosthesis listed in the attached letter (21/03/2011) (100 ko), at the following the detection of a failure to seal the secondary packaging of these implants, which could call into question the sterile barrier of the blister and the sterility at the outer surface of the inner packaging of the implants. The company BIOMET France has directly notified the recipients of the incriminated lots by means of the enclosed message validated by the Afssaps (21/03/2011) (100 KB). This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Implants for knee and hip prosthesis
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    Biomet France

Manufacturer

Biomet France
  • 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