International safety notice

Implant/Non-modular Stem for Hip Arthroplasty/Implantable Material/Femoral Component for Knee Arthroplasty

Brazil / Anvisa · BRA · Feb 5, 2016

Key facts

Title Implant/Non-modular Stem for Hip Arthroplasty/Implantable Material/Femoral Component for Knee Arthroplasty
Regulator Brazil / Anvisa
Country BRA
Brand POLISHED IMPLANTS PACKAGING IN LPDE POCKETS: 1. Femoral component without restriction with coating Registration Number: 80245480043 - Risk class III see attachment. 2. Cemented femoral stems Registration Number: 80245480038 - Risk class III see annex. 3. Femoral component with uncoated restriction - Registration Number: 80245480041 Risk class III see annex. Femoral component without restriction without coating Registration number: 80245480057 Risk class III see annex.
Manufacturer DETENTOR DO REGISTRO NO BRASIL EMPRESA WM WORLD MEDICAL LTDA RUA DO REZENDE 189 RIO DE JANEIRO RJ CNPJ 03179994000143 FABRICANTE ZIMMER INC WARSAW EUA
Models 80245480057, 80245480038, 80245480043, 80245480041
Date Feb 5, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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