Events

Rappel de Vanguard M Series Unicondylar Tibial Bearings

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 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
    71253
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1798-2015
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Date de publication de l'événement
    2015-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137046
  • 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, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • Cause
    The left and right orientation of the trial was incorrectly etched on one side. when the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows r on the same side as the keel marked lm and the l on the same side as the keel marked rm. this is incorrect. please note that the keel is not etched on this side by design.
  • Action
    On 4/22/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications, dated April 22, 2015 were sent to the affected distributors with instructions for 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. Customers are required to immediately locate and remove the affected product from circulation, follow the instructions on the "Response Form," and e-mail a copy of the completed form to the designated e-mail address prior to returning the product. Additionally, if the affected product has been further distributed, the necessary personnel must notified via the "Dear Risk/Recall Manager" notice. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Vanguard M Series Unicondylar Tibial Bearings
  • Modèle / numéro de série
    Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
  • Description du dispositif
    Vanguard M Unicondylar Tibial Trial || For use during knee joint replacement.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    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