Events

Field Safety Notices about PALACOS® and COPAL® bone cements

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 HERAEUS Medical 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
    2017-07-19
  • 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
    In individual cases, the secondary bag (polyethylene paper bag) of the bone cement products specified in the list may tear on opening, making sterile removal of the primary bag (cement powder bag) difficult. the reduced ability of the secondary bag to be torn open that is described here occurs due to the excessive tensile strength of the sealed seam. given identical sealing parameters, the batches of packaging material affected exhibit higher tensile strength of the sealed seams, which all however conform with the applicable standards.

Device

PALACOS® and COPAL® bone cements

Manufacturer

HERAEUS Medical GmbH