Safety Alert for Zimmer handpiece systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zimmer Surgical S.A..

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
    R1410-436
  • Event Number
    2009DM-0004066
  • Date
    2014-10-28
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 informs that he has initiated the withdrawal of universal feeding systems from the referenced devices, detecting the possibility that the handpiece is activated by itself when it is connected to the power supply, leading to the generation of possible adverse events on the patient or the user.

Device

  • Model / Serial
    Universal Power Systems, specific serials.
  • Product Description
    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 milling. It can operate depending on the reference driven or activated by: air or nitrogen (pneumatic), or powered by electric power: continuous (battery) or alternating electrical power with power cable of the local power network. It is used in large and small bone surgeries of hip, knee, foot, hand, shoulder. And its intention of use is to be used in surgery rooms.
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • 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