Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Meta Bio Industrial Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1779
  • Date
    2015-12-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.