Events

Rappel de Natural Knee II Revision Femoral Stem, 125mm

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
    71531
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1948-2015
  • Date de mise en oeuvre de l'événement
    2014-10-02
  • Date de publication de l'événement
    2015-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138115
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. if the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. the risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
  • Action
    On 10/2/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. through 8 p.m. ET.

Device

Natural Knee II Revision Femoral Stem, 125mm
  • Modèle / numéro de série
    item 6215-12-185 Lots: 7884165 7884736 7884737 7884738 7890330 11011448 11012660 60394169 60415420 60515793 60564530 60601129 60614014 60797044 60803056 60841848 60922655 60922656 60927853 60989112 61017152 61104192 61135872 61200531 61284571 61366919 61464308 61505310 61533025 61566733 61742151 61780361 61784264 61834192 61834778 61840307 61930376 61947884 61947885 62097910 62146925 62195165 62249431 62281270 62305675 62317987 62358643 62448678 62536901 62536902 62536903 62546527 62560372 62587577 62610989 62624715 62624716 62624717 62624718 62709664 62709665 62709667 62709670
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.
  • Description du dispositif
    Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
  • 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