Events

Recall of Cemented tibial bases size 3

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 Depuy.

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
    2006-12-26
  • 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-embases-tibiales-de-la-societe-depuy-2
  • 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
    DEPUY company has withdrawn from the market on November 23, 2006 all batches of references 149823003 and 149824003 of the medical device called "cemented tibial bases size 3 - Unicompartimentale Preservation range" following difficulties of assembly of the polyethylene insert in the base tibial. As a precaution, the DEPUY company extends the recall to all sizes 1,2,3,4,5 of these tibial bases that may have the same defect (references specified in the attached letter). No incidents of postoperative disassembly have been reported to date in the world. The company has directly notified the recipients of the incriminated references using the message attached (26/12/2006) (18 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, if necessary to the services concerned (surgeons, block supervisors). The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Cemented tibial bases size 3
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy