Events

Rappel de Device Recall Superior Approach Resection Guide Assembly

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
    65212
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1548-2013
  • Date de mise en oeuvre de l'événement
    2013-05-15
  • Date de publication de l'événement
    2013-06-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118271
  • 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, shoulder, semi-constrained, metal/polymer + additive, cemented - Product Code PAO
  • Cause
    Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. when the slot on the resection guide is offset in the wrong direction, the steinman pin that is intended to hold the guide into place may not come into contact with the bone.
  • Action
    On 5/15/2013 an URGENT MEDICAL DEVICE RECALL notification was sent to all consignees detailing to immediately locate and discontinue use of the product and return to Biomet. The following actions are REQUIRED: -Immediately locate and remove the identified device(s) listed below from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . -Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product. you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices.

Device

Device Recall Superior Approach Resection Guide Assembly
  • Modèle / numéro de série
    Catalog number: 010001814 and lot numbers: 318520 and 644720.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
  • Description du dispositif
    Superior Approach Resection Guide Assembly. || Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
  • 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