Events

Recall of Device Recall Pathfinder NXT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62325
  • Event Risk Class
    Class 2
  • Event Number
    Z-1981-2012
  • Event Initiated Date
    2012-06-05
  • Event Date Posted
    2012-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110228
  • Notes / Alerts
    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.
  • Extra notes in the data
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    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
  • Model / Serial
    Part numbers 3573-2 (straight handle) all lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
  • Product Description
    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.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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