Events

Rappel de (6) Vanguard CR E1 Bearings (7) BioMet Vanguard Knee Joint System (2) Biometric Bipolar System (3) E - 1 Hip Acetabular Liner (4) Complimentary Shoulder Fracture System ) Vanguard PS E1 Bearing (8) Active Articulation E1 (9) E1 Bipolar System (10) Compliant Reverse Shoulder System

Selon Pharmaceuticals and Medical Devices Agency, Japan, ce/cet/cette rappel concerne un dispositif en/au/aux/à Japan qui a été fabriqué par Zimmer · Biomet's Limited Liability Company.

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
    Recall
  • ID de l'événement
    2-7401
  • Date
    2017-04-13
  • Pays de l'événement
    Japan
  • Source de l'événement
    PMDAJ
  • URL de la source de l'événement
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-7401
  • Notes / Alertes
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 Japan.
  • Notes supplémentaires dans les données

Device

(6) Vanguard CR E1 Bearings (7) BioMet Vanguard Knee Joint System (2) Biometric Bipolar System (3...
  • Modèle / numéro de série
  • Description du dispositif
    (6) (7) Total artificial knee joint (2) (9) Artificial femoral head (3) (8) Artificial hip acetabular component (4) (10) Whole artificial shoulder joint (5) Artificial material for lower limb reconstruction Knee joint tibial component
  • Manufacturer
    Zimmer · Biomet's Limited Liability Company

Manufacturer

Zimmer · Biomet's Limited Liability Company
  • 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
    PMDAJ