Events

Safety Alert for Anchoring Sutures and Needles System JUGGERKNOT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biomet Sport Medicine || Zhejiang Biomet Medical Products Co. Ltd. || Changzhou Biomet Medical Devices Co. Ltd.

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
    R1605-196
  • Event Number
    2011DM-0008085
  • Date
    2016-05-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 tyvek seal could be weak, compromising the sterile barrier, leading to adverse events on patients.

Device

Anchoring Sutures and Needles System JUGGERKNOT
  • Model / Serial
    110005306, 110005307, 14-405040, 281001100, 805065080, 900360, 900364, 904723, 904755, 904756, 904834, 912029, || 912030, 912031, 912057, 912068, 912071 and 912076, lots || specific.
  • Product Description
    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...
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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