Rappel de Device Recall Prosthesis Shoulder Hemi Humeral Metallic Uncemented. ExploR, ExploR Radial Head

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer Biomet, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
  • Cause
    Zimmer biomet is conducting a medical device recall for the explor 6x24mm implantable stem with screw due to a complaint alleging that the modular radial hd lock screw was not included in the package for the stem.
  • Action
    Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex. On 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx


  • Modèle / numéro de série
    Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US, Canada, OUS.
  • Description du dispositif
    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. || The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.
  • Manufacturer


  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • 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