Events

Safety Alert for NEXGEN KNEE THREADING PINS, LOTS NO.S 71350300, 71915000

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

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
    50
  • Date
    2001-06-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The hexagonal head does not cause the driver to ensure the micro-mill femural assembly in the instrumentation surface in the surgical site. zimmer started removal by letter sent on april 2, 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE ZIMMER REMOVAL LETTER AND QUESTIONNAIRE ON APRIL 2, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. CONTACT YOUR ZIMMER REPRESENTATIVE TO RETURN THE AFFECTED PRODUCT. ZIMMER ENSURES REPLACEMENT OR COMPLETE REFUND, CONTACT CONNIE MORGAN, MANAGER, REGULATORY COMPLIANCE, BY MAIL (PO BOX 708, WARSAW, IN, 46581-0708 USA) OR FAX (0021-1-219-372-4265). FOR FURTHER INFORMATION CONTACT YOUR ZIMMER REPRESENTATIVE OR BY PHONE (0021-1-219-267-6131).

Device

NEXGEN KNEE THREADING PINS, LOTS NO.S 71350300, 71915000

Manufacturer

ZIMMER INC.
  • Source
    ANVSANVISA