Events

Recall of Prozir zirconia ceramic hip prosthesis 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 Saint Gobain Desmarquest Advanced Ceramics Company.

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
    2001-08-16
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/decision-du-16-aout-2001-de-suspension-d-utilisation-de-tetes-de-prothese-de-hanche-en-ceramique-de-zircone-prozir-lots-th-fabriquees-par-la-societe-saint-gobain-ceramiques-avancees-desmarquest-et-mis-sur-le-marche-par-les-societes-citees-ci-apres-
  • 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
    WARNING. : You have been the recipient of a first alert message. following the decision of August 10, 200. concerning the suspension of use of certain zirconia ceramic hip prosthesis heads produced by Saint Gobain Advanced Ceramics Desmarquest. This message established a list of manufacturers putting these devices on the market and therefore concerned by this measure. The company Saint Gobain Advanced Ceramics Desmarquest meanwhile has forwarded to the Afssaps a complementary list of 10 manufacturers (see below) having also put on the market ceramic heads zirconia lots TH :. AMM - AESCULAP ​​France - PROCOM NORT'ON - IMPLANT SERVICE - STILL ORTHOPEDICS - ARGOMEDICAL AG - MIL - PROSINTESE - STRATEC MEDICAL SA - BIOMET DEUTSCHLAND GmbH. A complementary decision. , including these 10 manufacturers was therefore taken on August 16, 2001. Each manufacturer quoted above will contact your establishment if it has delivered devices affected by this decision to specify models / references and lots affected by this measured.

Device

Prozir zirconia ceramic hip prosthesis heads

Manufacturer

Saint Gobain Desmarquest Advanced Ceramics Company
  • Source
    LAANSM