Events

Recall of Scorpio Femoral Femoral Components

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
    2008-03-20
  • 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-composant-femoraux-de-genou-scorpio-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 19/03/08, the company STRYKER France SAS removed the batches KNAMED and V8WMED from the medical device called Scorpio Femoral Femoral Components references 70-5211R and 71-5211R following the demonstration of an inversion of the femoral components of Scorpio knee part number 70-5211R batch KNAMED (Preservation Implant - CR) and 71-5211R lot V8WMED (Stabilized Postoperative Implant - PS) .. The company STRYKER directly warned the recipients of the incriminated lots with the help of the message attached (19/03/2008) (22 ko) validated by Afssaps .. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned .. The competent European authorities concerned) are informed of this measure by the manufacturer.

Device

Scorpio Femoral Femoral Components
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

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