Events

Recall of PE inserts for Apogee acetabulum

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 BIOTECHNI.

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
    2007-07-16
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-d-inserts-pe-double-mobilite-pour-cotyle-apogee-a-clip-retentif-biotechni
  • 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    The BIOTECHNI company has withdrawn from the market on July 16, 2007 all double-mobility PE inserts for Apogee acetabulum with retentive clip bearing IDM22-44 to IDM22-60 and IDM28-48 to IDM28-62 following some intraprosthetic dislocation incidents. . The company has directly notified the recipients of the incriminated units with the message attached (16/07/2007) (10 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary, to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

PE inserts for Apogee acetabulum
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BIOTECHNI

Manufacturer

BIOTECHNI
  • Source
    LAANSM