Events

Safety Alert for Osteosynthesis Material for Extremities

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 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
    R1612-566
  • Event Number
    2011DM-0007213
  • Date
    2016-12-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • 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 affirms that the affected lots of the referenced device may be incorrectly recorded and labeled, leading to the occurrence of possible adverse events on the patients.

Device

Osteosynthesis Material for Extremities
  • Model / Serial
    TFNA FEMORAL NAILS, reference 04.037.012S and 04.037.042S, lots H077853; H065031 and H067802.
  • Product Description
    The osteosynthesis material for SYNTHES extremities are nonabsorbable implants designed to help the immobilization, stable fixation and stabilization of the osseous fragments during the treatment of fractures, trauma, reconstruction and bone deformities, restoration of anatomical relationships and allowing an accurate bone approximation. There are different types of osteosynthesis implants corresponding to the bones of the extremities of the body, for example: femur, tibia, ulna, radius, humerus, hand, foot, etc. These osteosynthesis implants can be used or not in conjunction with the other osteosynthesis implants to immobilize the affected bone and fix in such a way to induce bone growth and fracture healing. The intramedullary nails together with the locking screws are used for the osteosynthesis of large bones such as the femur, the tibia and the humerus. The osteosynthesis implants of SYNTHES are classified according to their dimensions and shapes that makes them more suitable for different parts of the extremities of the body. , its traumas and pathologies. It is noted that these implants can be combined with the original parts of the same system.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh