Events

Alerte De Sécurité sur Trade name: Disposable applicator anchor - Meta Bio ;. ANVISA registration number: 80034760032 ;. Risk class: III. Affected model (s): 2831-020; 2831-027; 2831-030; 2831-035; 2831-040; 2831-045; 2831-050. Lot (s): Distribution map attached.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Meta Bio Industrial Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1779
  • Date
    2015-12-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    As registration holder, Disposable Applicator Anchor products manufactured by Meta Bio with the use of thread if sutures in UHMWPE (Ultra High Molecular Weight Polyethylene) material meet all the biocompatibility and mechanical requirements established by the reference standards, as well as to all use / application requirements, according to a comparative evaluation performed on the basis of national and international studies performed by medical researchers. At first, it is not necessary to follow the implanted patients, since the product will not go into failure mode after its implantation, that is, the suture can only rupture at the time of implantation.
  • Cause
    As evidenced by inspection carried out, the products of registration no. 80034760032 (disposable applicator anchor - meta bio) were manufactured using polyethylene suture wires (uhmwpe), this being divergent from the anvisa registry.
  • Action
    a) Classification of the risk: Class III b) Classification of the field action: collection of the products in the market with action of return to the manufacturer; c) Field action code: Anchor / 2015; d) recommendations to users and patients: payment of the remaining stock balance of the products subject to this notification to our Distributors. At first, it is not necessary to follow the implanted patients, since the product will not go into failure mode after its implantation, that is, the suture can only rupture at the time of implantation.

Device

Trade name: Disposable applicator anchor - Meta Bio ;. ANVISA registration number: 80034760032 ;....

Manufacturer

Meta Bio Industrial Ltda.