Events

Recall of Torque Limiter;Torque Limiter AxSOS

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
    2008-12-04
  • 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-de-tournevis-dynamometriques-torque-limiter-de-la-gamme-axsos-pour-vis-3-mm-stryker-trauma-ag
  • 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    On 03/12/2008, the company Stryker France has withdrawn from the market the batches of the reference references cited in the recall of the medical device called Torque Limiter screwdriver and screwdriver Torque Limiter AxSOS range for screw 3 mm, manufactured by Stryker Trauma AG, following several claims in the United States concerning the breakage of the tip of the AxSOS and AxSOS Torque Limiter 3 mm screwdrivers. The company Stryker directly notified the recipients of the incriminated lots with the attached message (04/12/2008) (25 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by manufacturer.

Device

Torque Limiter;Torque Limiter AxSOS
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

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