Events

Rappel de Device Recall Polaris Translation Screw System

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
    66300
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0359-2014
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • Date de publication de l'événement
    2013-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121961
  • 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
    Screw, fixation, bone - Product Code HWC
  • Cause
    Polaris translation screw failures were recently reported to biomet spine. these failures are generally described as dissociation of the screw head from the shaft of the polaris translation screw.
  • Action
    Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.

Device

Device Recall Polaris Translation Screw System
  • Modèle / numéro de série
    Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the  SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution including Puerto Rico.
  • Description du dispositif
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. || Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Adresse du fabricant
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • 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