Events

Alerte De Sécurité sur orthopedic surgery handpiece system

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Zimmer Surgical S.A..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1607-283
  • Numéro de l'événement
    2009DM-0004066
  • Date
    2016-07-18
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=132
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The importer informs that during a surgical procedure at the time of the patellar cut, the oscillating saw blade is not working and the surgery can not be performed, the manufacturer was notified and the product distributed in the local market was removed, with the objective of avoiding that possible adverse events occur on patients .

Device

orthopedic surgery handpiece system
  • Modèle / numéro de série
    Concerning the Oscillating Saw Adapter, reference 89- 8509-450-60, specific serial.
  • Description du dispositif
    It is a modular system used for orthopedic surgery, consisting of modular handpieces, motors, to which its accessories and adapters can be connected, allowing great versatility and precision during orthopedic surgical procedures: drilling, sawing and refining. It can work depending on the reference driven or activated by: air or nitrogen (pneumatic), or powered by electric power: continuous (battery) or alternating electric power with power cord of the local power network. It is used in large and small surgeries bone decadera, knee, foot, hand, shoulder. And his intention to use esque is used in surgery rooms.
  • Manufacturer
    Zimmer Surgical S.A.

Manufacturer

Zimmer Surgical S.A.
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA