Events

Safety Alert for Actifuse ABX 1-2mm, manufacturer Apatech, models 506005078047 (2,5mm); 506005078048 (5.0mm) and 506005078049 (10.0mm). Record 80253610018. Series Affected: See Annex.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Osteocamp Implantes e Materiais Cirúrgicos Ltda.; Apatech Limited..

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
    1736
  • Date
    2015-09-21
  • 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
    According to the company, in surgical procedures in which the device contacts the cerebrospinal fluid through a hard opening (iatrogenic injury), the use of a medical device that has increased endotoxin levels may increase the typical inflammatory reaction for surgery and contribute to adverse health consequences. There are no reports of adverse events.
  • Reason
    Product with endotoxin level test result above the specified limits, for a stability batch.
  • Action
    The company that holds the registration will collect and destroy products with an expiration date before 07/29/2017. Product distributors are advised to identify and segregate the product for later collection by the company.

Device

Actifuse ABX 1-2mm, manufacturer Apatech, models 506005078047 (2,5mm); 506005078048 (5.0mm) and 5...

Manufacturer

Osteocamp Implantes e Materiais Cirúrgicos Ltda.; Apatech Limited.
  • Source
    ANVSANVISA