Events

Safety Alert for spine supports and lower limb orthosis

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Össur Inc || Ossur HF.

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
    I1603-131
  • Event Number
    2014DM-0011389 ; 2014DM-0011021
  • Date
    2016-03-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 it has detected that the referenced products contain components with natural rubber latex not declared in the product, leading to the potential occurrence of adverse events in latex patients.

Device

spine supports and lower limb orthosis
  • Model / Serial
    COLLAR MIAMI J; UNDERSLEEVE, REBOUND and UNLODER, specific product numbers || respectively.
  • Product Description
    Advanced stabilization devices for the spine and cervical area. Designed to meet the specific requirements of the patient and the doctor .---- In the immobilization in trauma, general post-surgery, dislocations, to immobilize the lower limb, pre or post-surgical immobilization of lesions of the soft tissues, use in trauma and rehabilitation, postoperative stabilization of the ankle, stable fractures, detobillo sprain of grade 2 and 3. In collateral stabilization of the articulation in moderate instabilities, helps in moderate injuries of the lateral ligaments, demenis lesions, preventing hyperexpression, in instability of the medial and lateral ligaments , in minor or moderate joint stability, articulatory protection against the remissions of sprains when resuming sports activity. In the postoperative period in which some immobilization and gradual increase in movement, tendon injuries, fractures or dislocations of the tibiotarsal joint are required, conservative management of the Metatarsus and tarsus, functional therapy of Achilles tendon rupture, chronic ligament instabilities.
  • Manufacturer
    Össur Inc || Ossur HF

Manufacturer

Össur Inc || Ossur HF
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    NIDFSINVIMA