Events

Recall of Biomet Microfixation TraumaOne System Surgical Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Microfixation, LLC.

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
    77022
  • Event Risk Class
    Class 2
  • Event Number
    Z-2073-2017
  • Event Initiated Date
    2017-04-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154834
  • 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
    Template - Product Code HWT
  • Reason
    Part of the number on the tray lid differ from the part number on the base.
  • Action
    On April 11, 2017 the firm sent notifications to all affected US and International distributors, which will include instructions for returning affected products. All distributors will be notified via electronic mail, and US distributors with product, will be notified via courier. o Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals which currently have the product. o Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the additional accounts form provided in the letter. o Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. For more information contact corporatequality.postmarket@zimmerbiomet.com or 904-367-7133 (8:am - 5pm EST)

Device

Biomet Microfixation TraumaOne System Surgical Tray
  • Model / Serial
    Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, MO and UT Canada, Australia, Netherlands, and Egypt
  • Product Description
    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Manufacturer Address
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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