Events

Alerte De Sécurité sur Anchoring Sutures and Needles System JUGGERKNOT

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 Biomet Sport Medicine || Zhejiang Biomet Medical Products Co. Ltd. || Changzhou Biomet Medical Devices Co. Ltd.

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
    R1605-196
  • Numéro de l'événement
    2011DM-0008085
  • Date
    2016-05-06
  • 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=142
  • 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 manufacturer reports that the tyvek seal could be weak, compromising the sterile barrier, leading to adverse events on patients.

Device

Anchoring Sutures and Needles System JUGGERKNOT
  • Modèle / numéro de série
    110005306, 110005307, 14-405040, 281001100, 805065080, 900360, 900364, 904723, 904755, 904756, 904834, 912029, || 912030, 912031, 912057, 912068, 912071 and 912076, lots || specific.
  • Description du dispositif
    The soft anchors JUGGERKNOTTSON an implant completely based on suture that binds to fixation, detejido soft - bone. The JUGGERKNOT soft anchors consist of a manual assembly used to deploy a pre-loaded implant, the JUGGERKNOT soft anchor implant is a two-piece anchor design and the second one is a two suture strips, when the strip is braided the anchor part secures the bone, setting The soft tissue represents the next generation in anchoring suture technology. The 1.4mm anchor deployment design is a system entirely based on suture and is the first of its kind.
  • Manufacturer
    Biomet Sport Medicine || Zhejiang Biomet Medical Products Co. Ltd. || Changzhou Biomet Medical Devices Co. Ltd

Manufacturer

Biomet Sport Medicine || Zhejiang Biomet Medical Products Co. Ltd. || Changzhou Biomet Medical De...
  • 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