Events

Recall of BIOLOX alumina heads

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 SGM.

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
    2005-07-11
  • 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-tetes-en-alumine-biolox-de-la-societe-sgm
  • 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
    The SGM company has withdrawn from the market on July 6, 2005 batches 3756, 4233 and 4623 of the medical device called "heads BIOLOX alumina 32 mm medium diameter high diameter" reference SGM 34410 distributed by the companies ASTON Medical, PROCOM, ORSEDIS-SPENCER CRAWFORD , OCEAM and NORD IMPLANT following cases of fractures of these heads. The company has directly notified the recipients of the offending lot with the message attached (11/07/2005) (70 KB) validated and completed by Afssaps. This supplement, written by Afssaps after expert opinion, is a letter of recommendation (11/07/2005) (126 ko) relating to the follow-up of patients. This information is addressed to the directors of health establishments and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. This reminder only concerns France.

Device

BIOLOX alumina heads
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SGM

Manufacturer

SGM
  • Source
    LAANSM