Events

Field Safety Notices about TunneLoc Tibial Fixation Accessories Group

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia 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
    Field Safety Notice
  • Date
    2017-11-17
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Zimmer biomet implements a voluntary medical device (withdrawal) measure for the tunneloc tibial fixation device group for validation testing of gamma sterilization associated with external vendors of the package indicating that the sterilization dose may not be appropriate.

Device

TunneLoc Tibial Fixation Accessories Group
  • Model / Serial
    906512 all TIBIAL FIXATION TUNNELOC, 8 mm 906513 all TIBIAL FUNCTION TUNNELOC, 9 mm 906514 all TIBIAL FUNCTION TUNNELOC, 10 mm 906515 all TIBIAL FIXATION TUNNELOC, 11 mm 906532 all 8mm ANTERIOR CROSS LIGAMENT IN THE BOX 906533 all 9mm ANTERIOR CROSS LIGAMENT IN THE BOX 906534 all 10mm ANTERIOR CROSS LIGAMENT IN THE BOX 906535 all 11mm ANTERIOR CROSS LIGAMENT IN THE BOX
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • 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
    AMPMDRS