Events

Recall of UltraDriveTool, 6 MM Plug Puller

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    61685
  • Event Risk Class
    Class 3
  • Event Number
    Z-1521-2012
  • Event Initiated Date
    2012-04-18
  • Event Date Posted
    2012-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108716
  • 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
    Device, nerve conduction velocity measurement - Product Code JXE
  • Reason
    Incorrect product picture label was on the product box.
  • Action
    Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.

Device

UltraDriveTool, 6 MM Plug Puller
  • Model / Serial
    Catalog 423868 Lot 409680
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Europe, Austrailia
  • Product Description
    Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 || Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head || The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a controlled high speed. This action breaks down bone cement and cuts through cancellous bone.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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