Events

Safety Alert for BIOTECK Orthopedic Implants

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Bioteck Industria ,Comercio.

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
    R1706-239
  • Event Number
    2017DM-0016143
  • Date
    2017-06-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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 the referenced devices were marked with an incorrect lot number kdve15r, instead of appearing the one corresponding to pshc746, leading to potential confusion in the traceability of the device, a fundamental element of identification in case of presenting adverse events on patients.

Device

BIOTECK Orthopedic Implants
  • Model / Serial
  • Product Description
    Intervertebral spacer: indicated for posterior fixation surgery and intervertebral arthrodesis, for the treatment of lumbar and lumbosacral pathologies of the vertebral column where the intervertebral arthrodesis procedure is indicated, whether degenerative, traumatic, congenital or other. . Indicated for cases of need for fixation, such as cervical intersomatic arthrodesis, mainly in acute disc disorders (hernias) and in degenerative pathologies with chronic and limited instability.
  • Manufacturer
    Bioteck Industria ,Comercio

Manufacturer

Bioteck Industria ,Comercio