Events

Recall of UHR mobile cups

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 STRYKER.

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
    2007-11-28
  • 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-de-cupules-mobiles-uhr-de-la-societe-stryker
  • 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
    On November 27, 2007, the company STRYKER removed from the market the batches of the references specified in the appendix of the medical device called "mobile cups UHR", following the observation of the possibility that the assembly ring is not that of the corresponding cup making thus the insertion of the femoral head in the insert of the cupule impossible .. The company STRYKER directly warned the recipients of the incriminated lots with the message attached (28/11/2007) (26 ko) validated by Afssaps .. This information is addressed to the directors, pharmacists and correspondents of materiovigilance for dissemination if necessary to the services concerned .. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

UHR mobile cups
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

STRYKER
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    LAANSM