International Medical Devices Database

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.

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Type of Event
Recall
Date
2004-07-01
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-et-des-inserts-associes-de-la-societe-smith-et-nephew
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
Afssaps has been informed of a withdrawal of all batches of the references specified in the attached list (18/06/2004) (187 KB), of metal tibial bases and related inserts Genesis Uni made by the company SMITH and NEPHEW June 18, 2004, due to problems of intraoperative snap-fastening of the inserts on the tibial bases reported in the USA. No postoperative complication has been reported to date. The 12 health facilities concerned by this recall in France were warned directly.

Device

Tibial bases and associated inserts

Model / Serial
Product Description
medical_device
Manufacturer
SMITH and NEPHEW

Manufacturer

SMITH and NEPHEW

Source
LAANSM

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of Tibial bases and associated inserts

What is this?

Device

Tibial bases and associated inserts

Manufacturer

SMITH and NEPHEW