Events

Recall of CALMABLE Gaines

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 SERF.

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
    2008-03-28
  • 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-lot-de-gaines-calcinables-du-systeme-prothetique-multi-references-multi-lab-4-multi-lab-3-3-gtmu-3-3-societe-serf
  • 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 27/03/08, the company SERF removed from the market the batches of the references contained in the attached message of the medical device called CALMABLE Gaines of the prosthetic system MULTI references MULTI LAB 4 - MULTI LAB 3,3 - GTMU 3,3 , manufactured by SERF, following the demonstration of the fragility of certain VMU 1.2 T prosthetic screws packaged with burnout sheaths of the MULTI prosthetic prosthetic system. This fragility can result in the rupture of the screw head of prosthesis during tightening tests carried out on the prosthetic abutments MULTI with a torque lower than the recommended value. The company SERF directly warned the recipients of the incriminated batches with the message attached (27/03/2008) ( 16 kb) validated by Afssaps. The competent European authorities concerned are informed of this measure by the manufacturer.

Device

CALMABLE Gaines
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SERF

Manufacturer

SERF
  • Source
    LAANSM