Events

Avis De Sécurité sur PALACOS® and COPAL® bone cements

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par HERAEUS Medical GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-07-19
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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