Events

Field Safety Notices about Optipac® 40 Refobacin® Revision and Optipac® 80 Refobacin® Revision

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 Orthopedics Switzerland GmbH.

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
    2017-12-18
  • 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
    Biomet orthopedics switzerland gmbh implements a voluntary safety corrective action regarding a medical device (withdrawal) for certain batches of optipac® refobacin® revision products (see annex 1 for a list of potentially relevant products).

Device

Optipac® 40 Refobacin® Revision and Optipac® 80 Refobacin® Revision
  • Model / Serial
    OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C04670 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C05100 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B05130 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B06130 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B00240 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08910 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08920 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A01788 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A0178A OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A705C05628 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 B705B05128
  • Manufacturer
    Biomet Orthopedics Switzerland GmbH

Manufacturer

Biomet Orthopedics Switzerland GmbH
  • 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