Events

Rappel de Device Recall AGC Porous Patellar SM

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 Biomet, 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
    79095
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0627-2018
  • Date de mise en oeuvre de l'événement
    2017-08-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161330
  • 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
    The affected agc 2000 lp patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
  • Action
    Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall AGC Porous Patellar SM
  • Modèle / numéro de série
    Model No. 150802: Lot No. 305330 (UDI (01)00880304240230(17)220506(10)305330), 305340 ((01)00880304240230(17)220506(10)305330), 305350 ((01)00880304240230(17)220517(10)305350), 356750 ((01)00880304240230(17)220523(10)356750).
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution to IN, MO, NY, TX.
  • Description du dispositif
    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. || Product Usage: || For use in Total Knee Arthroplasty.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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