Events

Recall of Device Recall Vitality Spinal Fixation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet Spine 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
    77251
  • Event Risk Class
    Class 2
  • Event Number
    Z-2318-2017
  • Event Initiated Date
    2017-05-10
  • Event Date Posted
    2017-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155554
  • 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
    Accessories, fixation, spinal intervertebral body - Product Code LYQ
  • Reason
    Zimmer biomet is conducting a medical device recall for vitality t27 final drivers and vitality torque limiting handle  90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
  • Action
    Consignees will be notified on 5/15/17 via certified mail to return products.

Device

Device Recall Vitality Spinal Fixation System
  • Model / Serial
    Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
  • Product Description
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
  • Manufacturer
    Zimmer Biomet Spine Inc.

Manufacturer

Zimmer Biomet Spine Inc.
  • Manufacturer Address
    Zimmer Biomet Spine Inc., 10225 Westmoor Dr, Westminster CO 80021-2702
  • 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