Events

Safety Alert for System for Articular Prostheses for Elbow rHead Radial Head

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Small Bone Innovations Internacional.

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
    R1712-570
  • Event Number
    2010DM-0005229
  • Date
    2017-12-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=62
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that as a result of a review of the data currently available from the referenced devices found that it was not conclusive to continue supporting the performance of the device, consequently decided to withdraw the product from global markets, health professionals who have implanted patients should continue monitoring according to the protocol of usual attention, since the described situation could lead to the occurrence of adverse events on patients.

Device

System for Articular Prostheses for Elbow rHead Radial Head
  • Model / Serial
    RCNH2, RCNH3, RCNH4, RCNS1, RCNS160, RCNS2, RCNS260
  • Product Description
    To replace the head of the radio when there is degeneration due to arthritis or post-traumatic disability that presents pain, crepitus and decreased mobility in the radio-humeral bone or cubitoproximal radius, joint friction with articular destruction or subluxation visible on radiography and resistance to preservation of treatment for arthritis.
  • Manufacturer
    Small Bone Innovations Internacional

Manufacturer

Small Bone Innovations Internacional
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA