Events

Recall of Orthopedic implants

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.

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
  • Date
    2006-10-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-implants-orthopediques-de-la-societe-biomet
  • 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
    The company BIOMET has withdrawn from the market on October 23, 06 the batches and references specified in the appendix of the medical device called "orthopedic implants" following a malfunction in the cleaning process does not ensure sterility. To date, no complication associated with a loss of sterility has been reported on the batches concerned by this recall. The company has directly notified the recipients of the incriminated lots with the message attached (23/10 / 2006) (47 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local 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

Orthopedic implants
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BIOMET

Manufacturer

BIOMET
  • Source
    LAANSM