Events

Rappel de Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide

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 Trabecular Metal Technology, 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
    69866
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0851-2015
  • Date de mise en oeuvre de l'événement
    2014-12-02
  • Date de publication de l'événement
    2014-12-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131726
  • 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
    Probe - Product Code HXB
  • Cause
    During cleaning, two separate units of the nexgen tibial base plates did not fit with the tibial base plate handle.
  • Action
    Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are: 1. Locate all products from the identified lot above and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1) to the specified address. 4. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager letter directly. 5. Please notify Zimmer of any hospitals that you have further distributed the affected product to. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. Zimmer will notify the additional surgeons and hospitals you identify via Fed Ex mailing. The template will be emailed to you for completion and return to corporatequality.postmarket@zimmer.com. 6. Ensure that a copy of the Risk Managers 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 further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST. Biomet emailed a new letter with correct distribution dates on 1/16/2015.

Device

Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide
  • Modèle / numéro de série
    Part number 00-5887-045-00 Lot number 62592928
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
  • Description du dispositif
    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH || Zimmer U.K. Ltd., SN3 4FP, UK || Zimmer Trabecular Metal Technology, Inc || 10 Pomeroy Road, Parsippany, NJ 07054 USA
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • Adresse du fabricant
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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