Events

Recall of Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder

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
    62137
  • Event Risk Class
    Class 2
  • Event Number
    Z-1933-2012
  • Event Initiated Date
    2012-06-05
  • Event Date Posted
    2012-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109900
  • 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
    Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. the complaint investigation showed the hex mating feature of the set screw was broken and material missing. there were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we.
  • Action
    The firm, Zimmer Spine, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the notification and ensure they are aware of the content; to immediately remove and discontinue use of Pivoting Percutaneous Rod Holder (part number 3564-1) from Pathfinder NXT instrument sets in their possession and follow the PathFinder NXT Surgical Technique; to notify their Zimmer Spine customer service representative to obtain return authorization; and return the complete Surgeon Contact Certification Form within 10 working days from receipt of notification to ronald.musselman@zimmer.com or Fax to 1-512-258-0995. If you have any questions, call Zimmer Spine Customer Service at 866-774-6368.

Device

Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder
  • Model / Serial
    Part number 3564-1; all lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
  • Product Description
    PathFinder NXT Pivoting Percutaneous Rod Holder || This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
  • 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