Events

Rappel de BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION 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 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
    59911
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0076-2012
  • Date de mise en oeuvre de l'événement
    2011-09-16
  • Date de publication de l'événement
    2011-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103982
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Cause
    Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the microplasty taperloc 7.5mm resection guide. the above lots, as supplied to biomet by a vendor, are engraved on only one side. to date, biomet has received 2 reports involving 2 units where the instrument was missing the engraving on one side.
  • Action
    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM.

Device

BIOMET MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE
  • Modèle / numéro de série
    Part 31-555597, lot numbers: 476500, 572420, 663220, 812350, & 472890.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.
  • Description du dispositif
    MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. || This device is used to mark the femoral neck resection level
  • 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