Events

Field Safety Notices about Optipac

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 Biomet France SARL .

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
    2016-08-17
  • 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
    This advisory notice is to inform you about a product non conformity which affects the packaging of the optipac 60 refobacin bone cement listed above. our records indicate that you received at least one of the affected batches. we kindly request you to follow the recommendations below. biomet france sarl has initiated this action after having received a complaint indicating that an optipac 60 refobacin bone cement r was packaged in an optipac 40 refobacln bone cement r folding box. .

Device

Optipac
  • Model / Serial
    4711500396-1 OPTIPAC 60 REFOBACIN BONE CEMENT R A538308715 4711500396-1 OPTIPAC 60 REFOBACIN BONE CEMENT R A540308715 4711500396—1 OPTIPAC 60 REFOBACIN BONE CEMENT R A601C09945
  • Manufacturer
    Biomet France SARL

Manufacturer

Biomet France SARL
  • 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