Events

Recall of Cotyloid implants inserts alumina

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 Fournitures Hospitalières Orthopedics.

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
    2002-06-13
  • 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-d-implants-cotyloidiens-inserts-alumine-effectue-par-la-societe-fh-orthopedics
  • 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 June 4, 2002, the company Fournitures Hospitalières Orthopedics informed Afssaps of a recall it made on May 30 concerning prostheses of hip prostheses of ranges ATLAS and CORIOLIS. The file is being evaluated as part of the follow-up of incidents recorded in materovigilance (11 ruptures on approximately 3000 implanted prostheses). References and batches of alumina inserts concerned by the recall made by the company HOURS INDUSTRIAL HOSPITALS. CORIOLIS ALUMINE range. Reference 240087, diameter 50/28: all the batches prior to the batch n ° D1409 included are recalled. Reference 240088, diameter 52/28: all the batches prior to lot no. D1410 inclusive are recalled. Reference 240089, diameter 54/28: all the batches prior to lot no. D1416 inclusive are recalled. Reference 240090, diameter 56/28: all the batches prior to lot no. D1417 included are recalled. Reference 240091, diameter 58/28: all the batches prior to lot no. D1423 inclusive are recalled. Reference 240092, diameter 60/28: All batches prior to lot no. D1429 inclusive are recalled. ATLAS range ALUMINUM WITH ANTI-LUXURY WALL. Reference 234104, diameter 50/28: all the batches prior to lot no. E0753 inclusive are recalled. Reference 234105, diameter 52/28: all the batches prior to the batch no. E0754 included are recalled. Reference 234106, diameter 54/28: all the lots prior to lot no. E0755 inclusive are recalled. Reference 234107, diameter 56/28: all the batches prior to lot no. E1074 inclusive are recalled. Reference 234108, diameter 58/28: all the lots prior to lot no. E1077 inclusive are recalled. Reference 234109, diameter 60/28: All batches prior to lot no. E0877A inclusive are recalled. Reference 234110, diameter 62/28: all the batches prior to lot no. E1146 included are recalled. ATLAS range ALUMINUM WITH FLAT EDGE. Reference 242386, diameter 52/28: all the lots prior to lot no. 100052 included are recalled. Reference 242389, diameter 58/28: all the lots prior to lot no. D0011 included are recalled. Reference 242390, diameter 60/28: all the batches prior to lot no. D0221 included are recalled. Reference 242391, diameter 62/28: all the batches prior to lot no. D0020 inclusive are recalled.

Device

Cotyloid implants inserts alumina

Manufacturer

Fournitures Hospitalières Orthopedics
  • Source
    LAANSM