Events

Recall of Dental - Radiographic Transparencies for Certain Conical Implants with External Connection - ART 1036

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Biomet 3i.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    201516137
  • Date
    2015-12-10
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/dentaire-transparents-radiographiques-pour-implants-coniques-certain-a-connexion-externe-art-1036-biomet-3i-rappel
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    ANSM has been informed of the implementation of a product withdrawal carried out by BIOMET 3i. The users concerned received the attached mail (10/12/2015) (216 KB). This safety action is registered with the ANSM under the number 201516137. You will be able to consult its progress report on the Directory of the signaling of materialovigilanc. by entering this registration number.

Device

Dental - Radiographic Transparencies for Certain Conical Implants with External Connection - ART ...
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Biomet 3i

Manufacturer

Biomet 3i
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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