Events

Avis De Sécurité sur Hip, Knee and Shoulder products with a high polished surface packaged in LDPE (Low Density Polyethylene) pouches

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 Zimmer Biomet.

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
    2016-01-25
  • 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
    This notification is a follow up to the correction notice provided in august 2013. at that time and after a thorough investigation into the cause of the issue, zimmer biomet implemented a change to package the highly polished implants with a new ldpe bag. testing has shown that this new bag resolves the issue and prevents the bag from adhering to the implants. nonetheless, zimmer biomet has continued to receive complaints that the old ldpe bag containing the implant adheres to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 12,800 cases. accordingly zimmer biomet is removing the affected product remaining in the field. .

Device

Hip, Knee and Shoulder products with a high polished surface packaged in LDPE (Low Density Polyet...

Manufacturer

Zimmer Biomet
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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