Events

Rappel de Device Recall Zimmer Universal Locking 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 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
    72944
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0654-2016
  • Date de mise en oeuvre de l'événement
    2015-12-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142561
  • 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
    The product on the package label did not match what was inside the package. the label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
  • Action
    On 12/9/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital risk managers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Specifically, customers were asked to review the notification and ensure all affected personnel are aware of the information; assist the Zimmer Biomet sales representative with the quarantine and removal of any of the identified affected product; and complete and return the Certificate of Acknowledgement form. If after reviewing this notification customers have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.

Device

Device Recall Zimmer Universal Locking System
  • Modèle / numéro de série
    Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
  • Description du dispositif
    Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate || Straight 11 Holes 144mm Length || Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate || 8 Holes 105mm Length. || Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, 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