Events

Safety Alert for INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 80145901733. Code: 352.260S, Lot 2671884

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH.

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
    1737
  • Date
    2015-11-12
  • 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
    The company reports that the leachate (liquefied constituents) of a non-biocompatible device can generate an adverse reaction to the tissue. This is an undesired and excessive inflammatory response to foreign material (chemical, biological or physical) within the body. Medical or surgical treatment is ideal and no permanent impairment is expected. The possibility of such damage is considered remote since the material used in the device has been submitted and approved in the package integrity test (integrity of the seal and integrity of the sterile barrier) and biocompatibility and is stable after sterilization by an expiration date of 2 years.
  • Reason
    The expiration date on the product label has been found to be incorrect. existing tests confirm an expiration date of 2 years from the date of manufacture. the affected products on the market were labeled with an expiration date of 10 years. biocompatibility tests support an expiration date of 2 years only.
  • Action
    The company is performing the product collection and guides to identify and separate the involved lot and return it to its representative. (Field Action Code: R2014085)

Device

INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 801459...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH