Events

Rappel de Device Recall Zimmer Periarticular Locking Plate System

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
    68657
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2131-2014
  • Date de mise en oeuvre de l'événement
    2014-06-10
  • Date de publication de l'événement
    2014-07-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128400
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
  • Action
    Zimmer sent an Urgent Medical Device Recall letter dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They instructed their distributors to do the following: 1. Please locate, quarantine, and return the affected product (part number 00-2358-014-04; lot 62276042) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager and Surgeon letter directly. Additionally, Risk Managers and Surgeon that were identified via invoice data will also receive a letter directly. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7.If after reviewing this notification you have questions or concerns, please call 1-877-946-2761. They instructed the Surgeons and Risk Managers to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Inspect inventory for part number 00-2358-014-04; lot number 62276042. Quarantine the device and contact your Zimmer sales representative to remove and return the affected device. 3. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.

Device

Device Recall Zimmer Periarticular Locking Plate System
  • Modèle / numéro de série
    Part Number 00-2358-014-04; lot 62276042
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
  • 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