Events

Safety Alert Or Field Safety Notices for Various trauma guide wires

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Zimmer Biomet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-09-24
  • Event Date Posted
    2018-09-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/various-trauma-guide-wires-risk-of-infection-due-to-packaging-failure-mda-2018-032
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by zimmer biomet with expiry dates prior to 31 may 2028 – wire may breach packaging, compromising sterility of device.
  • Action
    Locate, quarantine and return all affected product. Return acknowledgement document to manufacturer (or complete online form as stated in the Field Safety Notice (FSN)).

Device

Various trauma guide wires
  • Model / Serial
  • Product Description
    Affected devices with expiry date prior to 31 May 2028:Item Number Item Description 469360 green 469340 yellow 469320 green 469060 yellow 469055 green 469040 yellow 469020 green 467265 yellow 467260 green 467220 yellow 29402 green 14-443053 yellow 14-443023 green 14-441053 yellow
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Manufacturer Address
    Zimmer Biomet Red Dragon Court, Unit 2, South Road Bridgend Industrial Estate Bridgend South Wales CF13 3PTTel: 01656 333932 Email: fieldaction.uk@zimmerbiomet.com
  • 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
    MHRA