Events

Rappel de Device Recall Endo & Unipolar Femoral Heads

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, 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
    Recall
  • ID de l'événement
    68818
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2547-2014
  • Date de mise en oeuvre de l'événement
    2014-07-22
  • Date de publication de l'événement
    2014-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129069
  • 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
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • Action
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Endo & Unipolar Femoral Heads
  • Modèle / numéro de série
    Item Numbers  00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Endo & Unipolar Femoral Heads: || ENDO FEMORAL HEAD 41MM DIA || ENDO FEMORAL HEAD 42MM DIA || ENDO FEMORAL HEAD 43MM DIA || ENDO FEMORAL HEAD 44MM DIA || ENDO FEMORAL HEAD 45MM DIA || ENDO FEMORAL HEAD 46MM DIA || ENDO FEMORAL HEAD 47MM DIA || ENDO FEMORAL HEAD 48MM DIA || ENDO FEMORAL HEAD 49MM DIA || ENDO FEMORAL HEAD 50MM DIA || ENDO FEMORAL HEAD 51MM DIA || ENDO FEMORAL HEAD 52MM DIA || ENDO FEMORAL HEAD 53MM DIA || ENDO FEMORAL HEAD 54MM DIA || ENDO FEMORAL HEAD 55MM DIA || ENDO FEMORAL HEAD 57MM DIA || ENDO FEMORAL HEAD 60MM DIA || ENDO FEMORAL HEAD 63MM DIA || ENDO FEM HEAD 41MM || ENDO FEM HEAD 42MM || ENDO FEM HEAD 43MM || ENDO PROS HEAD 44MM || ENDO FEM HEAD 45MM || ENDO FEM HEAD 46MM || ENDO FEM HEAD 47MM || ENDO FEM HEAD 48MM || ENDO FEM HEAD 49MM || ENDO FEM HEAD 50MM || ENDO FEM HEAD 51MM || ENDO FEM HEAD 52MM || ENDO FEM HEAD 53MM || ENDO FEM HEAD 54MM || ENDO FEM HEAD 55MM || ENDO FEM HEAD 57MM || ENDO FEM HEAD 60MM || ENDO FEM HEAD 63MM || UNIPOLAR COMPONENT, 41MM || UNIPOLAR COMPONENT, 42MM || UNIPOLAR COMPONENT, 43MM || UNIPOLAR COMPONENT, 44MM || UNIPOLAR COMPONENT, 45MM || UNIPOLAR COMPONENT, 46MM || UNIPOLAR COMPONENT, 47MM || UNIPOLAR COMPONENT, 48MM || UNIPOLAR COMPONENT, 49MM || UNIPOLAR COMPONENT, 50MM || UNIPOLAR COMPONENT, 51MM || UNIPOLAR COMPONENT, 52MM || UNIPOLAR COMPONENT, 53MM || UNIPOLAR COMPONENT, 54MM || UNIPOLAR COMPONENT, 55MM || UNIPOLAR COMPONENT, 56MM || UNIPOLAR COMPONENT, 57MM || UNIPOLAR COMPONENT, 58MM || UNIPOLAR COMPONENT, 59MM || UNIPOLAR COMPONENT, 60MM
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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