Events

Recall of Lepine Group head impactors, references HL 1300-011 and HLA TI 002

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 Groupe Lepine.

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
    2002-12-05
  • 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-des-impacteurs-de-tete-groupe-lepine-references-hl-1300-011-et-hla-ti-002
  • 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
    In agreement with Afssaps, Groupe Lepine is recalling all HL 1300-011 head impactors and sleeves associated with these HLA TI 002 reference bits. A letter was sent to the user centers to inform them of reminder of these references and information is disseminated to all materovigilance correspondents via the Viafax fax alert system

Device

Lepine Group head impactors, references HL 1300-011 and HLA TI 002
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Groupe Lepine

Manufacturer

Groupe Lepine