Events

Recall of BONECUTTER full radius 5.5 mm

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 SMITH and NEPHEW.

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
    2009-05-13
  • 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-de-couteaux-steriles-a-usage-unique-bonecutter-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
    On May 11, 2009, the company SMITH and NEPHEW withdrew from the market lots 20154971 and 20148707 of the reference 7206010 of the medical device called "sterile shaving knives for single use - BONECUTTER full radius 5.5 mm", following a possible defect of sealing at the level of the packaging. The company SMITH and NEPHEW has directly notified the recipients of the incriminated lots with the message attached (13/05/2009) (42 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 the manufacturer.

Device

BONECUTTER full radius 5.5 mm
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SMITH and NEPHEW

Manufacturer

SMITH and NEPHEW
  • Source
    LAANSM