Events

Rappel de Device Recall Pathfinder NXT

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 Zimmer, 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
    62325
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1981-2012
  • Date de mise en oeuvre de l'événement
    2012-06-05
  • Date de publication de l'événement
    2012-07-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110228
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Cause
    Zimmer is recalling pathfinder nxt fixed percutaneous rod holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
  • Action
    Zimmer sent an Urgent Medical Device Correction and Removal notification dated June 5, 2012 to distributors and all affected accounts of Zimmer Spine. The notice identified the affected products, problem and actions to be taken. Distributors were asked to hand deliver Recall Notices to Surgeons and return the completed Surgeon Contact Certification Form within 10 working days to ronald.musselman@zimmer.com or FAX to 1-512-258-0995. Notices to Surgeons and User facilities included revised directions/precautions for the Instructions for Use and attached Surgical Techique. Devices will be removed once newly design parts become available. For any related questions or assistance about this please contact Zimmer Spine Customer Service at 866-774-6368.

Device

Device Recall Pathfinder NXT
  • Modèle / numéro de série
    Part numbers 3573-2 (straight handle) all lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
  • Description du dispositif
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. || Product Usage: || PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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