Events

Safety Alert for All IMPLANTABLE PRODUCTS manufactured by the company. Locking System for Twister Column System - Registration: 80297610001 /// Hook for Twister column system - Registration 80297610002 /// Luminni cemented ceramic backplate - Register: 80297610003 /// Rods for column system Twister - Register: 80297610004 /// Stainless steel alloy femoral head - Registration: 80297610006 /// ET device - Registration 80297610007 - Luminni cobalt molybdenum chromium alloy femoral socket - Register: 80297610008 /// hexalobular and hexagonal Twister locking screw - Registration: 80297610013 /// PCL Cannulated Ligature Screw - Registration: 80297610015 /// PLS Solid Ligature Screw - Registration: 80297610016 /// Ancoraggi Titanium Bone Anchors - Registration 80297610017 /// Luminni Polyethylene Cement-Based Receptacle - Registration 80297610018 // / Femoral head of zirconia - Registration: 80297610019 /// Transverse locking connector - CTT - Registration: 80297610020 /// Femoral head of alumina - Regist Ro: 80297610021 /// Twister Bolts - Registration: 80297610022 /// Femoral stem of luminni chromium alloy - Registration: 80297610023 /// Titanium bone anchor Ancoraggi Eco - Registration: 80297610024 /// Cervical cage - Registration: 80297610025 // / ETD8 - Registration: 80297610026 /// Pins for garden technique - Registration: 80297610062 /// Suture screw - Registration: 80297610078 /// Lumini Cementless Rod - Register: 80297610079

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Lima Corporate Indústria e Comércio de Produtos Médicos Hosp. 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
    1771
  • Date
    2015-12-21
  • 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
    Company shall collect all batches / series of related products that have not yet been implemented. /// The company was notified by ANVISA to present a plan to follow up the patients who had implanted products and a Message model to the doctors clarifying in relation to the measures to be adopted with the patients who had implanted products.
  • Reason
    It was verified during investigative inspection that the company produces its products in disagreement with good manufacturing practices.
  • Action
    ANVISA determined the suspension of manufacture, distribution, commercialization and implantation of all the IMPLANTABLE PRODUCTS previously related, as well as determined the collection of said products available in the market.

Device

All IMPLANTABLE PRODUCTS manufactured by the company. Locking System for Twister Column System - ...

Manufacturer

Lima Corporate Indústria e Comércio de Produtos Médicos Hosp. Ltda
  • Source
    ANVSANVISA