Alerta De Seguridad para INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 80145901733. Code: 352.260S, Lot 2671884

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.

The company reports that the leachate (liquefied constituents) of a non-biocompatible device can generate an adverse reaction to the tissue. This is an undesired and excessive inflammatory response to foreign material (chemical, biological or physical) within the body. Medical or surgical treatment is ideal and no permanent impairment is expected. The possibility of such damage is considered remote since the material used in the device has been submitted and approved in the package integrity test (integrity of the seal and integrity of the sterile barrier) and biocompatibility and is stable after sterilization by an expiration date of 2 years.