Events

Recall of Right and left UNIX blade guide

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;PORTE.

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
    2006-07-25
  • 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-de-guide-lame-droit-et-gauche-de-la-societe-porte-distribues-par-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
    The company STRYKER France has withdrawn the lots, specified in the attached message, the medical device called "right and left UNIX blade guide" references E03005013L and E03005013R (manufactured by the company PORTE) following the highlighting of devices engraved with a wrong reference (error between the 2 references E03005013L / left and E03005013R / right) .. These blades are used for the installation of knee prostheses UNIX .. The company has directly notified the recipients of the incriminated lots using of the attached message (25/07/2006) (24 ko) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned. .. This reminder only concerns France.

Device

Right and left UNIX blade guide
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER;PORTE

Manufacturer

STRYKER;PORTE
  • Source
    LAANSM