Events

Recall of Tibial inserts PLUS Endoprothetik, ref RT-PLUS and RT-PLUS Modular 17mm

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 Endoprothetik.

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
    2003-08-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-inserts-tibiaux-plus-endoprothetik-ref-rt-plus-et-rt-plus-modular-17mm
  • 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
    PLUS Endoprothetik informed Afssaps on August 05, 2003 that since July 31, 2003, it has been recalling the RT-PLUS and RT-PLUS Modular polyethylene tibial inserts of 17 mm thickness, following the rupture of one of these inserts occurred in Greece in May 2003 .. The references recalled are. 24049, 24059, 24069, 24079 and 24089 (inserts with clamps 24044, 24054, 24064, 24074 and 24084 (inserts without clamps) 71 tibial inserts RT-PLUS and RT-PLUS Modular 17 mm thick were distributed in France some 30 have been implanted, and no other incident concerning these references has been notified to materiovigilance.

Device

Tibial inserts PLUS Endoprothetik, ref RT-PLUS and RT-PLUS Modular 17mm

Manufacturer

PLUS Endoprothetik
  • Source
    LAANSM