Alerta De Seguridad para 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.

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.

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.