Events

Recall of Device Recall Trinica

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    29908
  • Event Risk Class
    Class 2
  • Event Number
    Z-0040-05
  • Event Initiated Date
    2004-08-24
  • Event Date Posted
    2004-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34756
  • 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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Reason
    To date, there has been one complaint reported. during a trinica surgical case, the surgeon was provided a standard disposable, trinica drill bit (part number 07.00166.001) for use with the trinica all through one drill guide instrumentation, instead of the all through one drill bit. this enabled the physician to drill a few millimeters further than expected.
  • Action
    The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.

Device

Device Recall Trinica
  • Model / Serial
    Serial Numbers: ATO-001 through ATO-0082
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
  • Product Description
    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
  • Manufacturer
    Zimmer Spine, Inc.

Manufacturer

Zimmer Spine, Inc.
  • Manufacturer Address
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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