Events

Recall of Device Recall Biomet Dual Offset Broach Handle, Clamping Style

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
    51693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1352-2009
  • Event Initiated Date
    2009-03-31
  • Event Date Posted
    2009-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81001
  • 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
    orthopedic instrument - Product Code LXH
  • Reason
    The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
  • Action
    Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.

Device

Device Recall Biomet Dual Offset Broach Handle, Clamping Style
  • Model / Serial
    Lots 066960, 141030, 147350, 316150, 401870, 401890, 523100, 604190, 829920, 899350 and 901600.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Finland.
  • Product Description
    Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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