Events

Rappel de Device Recall Zimmer Hgp ii acetabular cup bone Screw

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 Manufacturing B.V..

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
    73981
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1683-2016
  • Date de mise en oeuvre de l'événement
    2016-05-04
  • Date de publication de l'événement
    2016-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145987
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Cause
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Action
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

Device

Device Recall Zimmer Hgp ii acetabular cup bone Screw
  • Modèle / numéro de série
    LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 || Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 || Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 || Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 || Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 || Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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
    USFDA