Events

Rappel de Device Recall NexGen LPS

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 ORTHOPEDIC MFG LTD.

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
    78960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0663-2018
  • Date de mise en oeuvre de l'événement
    2017-07-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160970
  • 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, metal/polymer, mobile bearing - Product Code NJL
  • Cause
    There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
  • Action
    On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131

Device

Device Recall NexGen LPS
  • Modèle / numéro de série
    Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
  • Description du dispositif
    NexGen LPS Femoral Component, Left and Right, Size G || Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
  • Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD

Manufacturer

ZIMMER ORTHOPEDIC MFG LTD
  • Adresse du fabricant
    ZIMMER ORTHOPEDIC MFG LTD, Building No 2 East Park, Shannon Industrial Estate, Shannon Ireland
  • 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