Events

Safety Alert for ADJUSTABLE SILICON PLATED NICKEL THERMOPLASTIC SOCKET ADAPTERS MODEL 2065. IDENTIFIER: LOT NOS: AT 0199-2, AT 0799-8

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CENTURY XXII INNOVATIONS INC; RSLSTEEPER LTD.

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
    136
  • Date
    2000-09-22
  • 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 united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
  • Action
    MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.

Device

ADJUSTABLE SILICON PLATED NICKEL THERMOPLASTIC SOCKET ADAPTERS MODEL 2065. IDENTIFIER: LOT NOS: A...

Manufacturer

CENTURY XXII INNOVATIONS INC; RSLSTEEPER LTD
  • Source
    ANVSANVISA