Events

Alerte De Sécurité sur m/l taper with kinectiv technology femoral stems and necks

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Zimmer.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-06-23
  • Date de publication de l'événement
    2015-06-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150623.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: zimmer m/l taper with kinectiv technology femoral stems and necks the united states food and drug administration (fda) has issued medical device safety alerts concerning m/l taper with kinectiv technology femoral stems and necks, manufactured by zimmer. the manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product. the manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. use of these products may require the need for a revision surgery to replace the affected implant. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1699-2015&w=06172015&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm452012.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451936.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 june 2015.

Device

m/l taper with kinectiv technology femoral stems and necks
  • Modèle / numéro de série
  • Classification du dispositif
    Orthopedic Devices
  • Description du dispositif
    Medical Device Safety Alert: Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 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
    DH