Events

Rappel de Device Recall Cypher MIS Screw Inserter

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 Ebi, Llc.

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
    68526
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1811-2014
  • Date de mise en oeuvre de l'événement
    2014-05-15
  • Date de publication de l'événement
    2014-06-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128143
  • 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
    Screwdriver - Product Code HXX
  • Cause
    The cypher mis screw inserter may exhibit an increased rate of instrument tip failure.
  • Action
    Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.

Device

Device Recall Cypher MIS Screw Inserter
  • Modèle / numéro de série
    Catalog Number 14-501669; Lot Number 006731
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country The Netherlands.
  • Description du dispositif
    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Adresse du fabricant
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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