Events

Rappel de Device Recall Intramedullary Bone Saw

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
    67618
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1243-2014
  • Date de mise en oeuvre de l'événement
    2014-02-26
  • Date de publication de l'événement
    2014-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125848
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Incorrect labeling on specific lots of the intramedullary bone saw. the saw blade assembly was identified as cam assembly.
  • Action
    The firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the FAX Back Response Form and reply within three (3) business days; complete and return Form via Fax to: 574-372-1683 prior to return of product, and use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via enclosed "Dear Risk/Recall Manager Notice", and note that you are charged with the location and return of these products. Shipping address is Return Goods, 56 E. Bell Drive Warsaw, IN 46582. Questions related to the notice should be directed to 574-372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Intramedullary Bone Saw
  • Modèle / numéro de série
    Lot 239430, 239450
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • Description du dispositif
    Part 475625, Intramedullary Bone Saw, Cam Assembly || Size 13 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
  • 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