Events

Recall of TM Ardis Interbody System Inserter

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
    63559
  • Event Risk Class
    Class 2
  • Event Number
    Z-0659-2013
  • Event Initiated Date
    2012-09-20
  • Event Date Posted
    2013-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114205
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Zimmer spine is has received complaints of difficulty in turning the implant release knob of the tm ardis inserter after final positioning of the tm ardis interbody spacer implant. there has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. the correction includes revised directions explaining the technique to remove the implant.
  • Action
    Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.

Device

TM Ardis Interbody System Inserter
  • Model / Serial
    Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA nationwide; Europe, Sweden
  • Product Description
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. || The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
  • 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