Events

Recall of 5.5 mm arthroscopic burs from Stryker

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 STRYKER.

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
    2005-03-02
  • 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-fraises-arthroscopiques-5-5-mm-de-la-societe-stryker
  • 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 was informed by STRYKER of the withdrawal of the market on February 21, 2005 from the references and batches specified in the attached message, the medical device called "5.5 mm arthroscopic cutters" following reports of patient burns due to overheating resulting from the combination of 3 conditions (oversize inner sleeve of the burs, applying excessive force and not activating the suction function, contrary to the instructions for use). No incident has been reported in France. The company Stryker directly notified the recipients of the lots concerned with the attached message (21/02/2005) (109 KB). The relevant European Competent Authorities have informed by the manufacturer of this measure.

Device

5.5 mm arthroscopic burs from Stryker
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

STRYKER
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    LAANSM