Events

Recall of TC-Plus and RT-Plus range

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 PLUS ORTHOPEDICS.

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
    2007-12-13
  • 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-d-implants-de-genou-de-la-gamme-tc-plus-et-rt-plus-plus-orthopedics
  • 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 December 10, 2007, the company PLUS ORTHOPEDICS removed from the market the batches of the references specified in the attached reminder message, of the medical device called "knee implants of the TC-Plus and RT-Plus range", following an error composition of the alloy used to make these implants. The company ORTHOPEDICS France has directly notified the recipients of the incriminated lots with the message attached (13/12/2007) (22 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

TC-Plus and RT-Plus range
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PLUS ORTHOPEDICS

Manufacturer

PLUS ORTHOPEDICS
  • Source
    LAANSM