Events

Recall of Device Recall ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION

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
    66499
  • Event Risk Class
    Class 2
  • Event Number
    Z-0589-2014
  • Event Initiated Date
    2013-11-05
  • Event Date Posted
    2013-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123984
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Reason
    Based on a review of historic packaging validations, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.
  • Action
    On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.

Device

Device Recall ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION
  • Model / Serial
    Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    ITST THREADED GUIDE PIN
  • 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