Events

Recall of Arrow shoulder prostheses

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 IMPLANTS INDUSTRIE.

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
    2008-03-10
  • 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-de-lots-de-dispositifs-de-la-gamme-protheses-d-epaule-arrow-implants-industrie
  • 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 March 6, 2008, the company FH ORTHOPEDICS removed from the market the batches of the references specified in the appendix (06/03/2008) (13 KB) of the medical devices called "glénosphère, glena base, handle of the range prostheses d 'shoulder ARROW', manufactured by IMPLANTS INDUSTRIE following the finding of a difficulty of adaptation with instruments and implants manufactured currently by FH Industrie. The company FH ORTHOPEDICS has directly notified the recipients of the incriminated lots with the enclosed message (06/03/2008) (14 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 will be informed by Afssaps.

Device

Arrow shoulder prostheses

Manufacturer

IMPLANTS INDUSTRIE