Events

Recall of Device Recall Trochanteric Nail. Long,

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
    61658
  • Event Risk Class
    Class 2
  • Event Number
    Z-1478-2012
  • Event Initiated Date
    2012-03-30
  • Event Date Posted
    2012-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108656
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    The trochanteric nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation.
  • Action
    Biomet sent an Urgent Medical Device Recall Notice dated April 18, 2012 to all affected consignees. The letter identified the affected product, reason for the recall including risks involved and actions to be taken. The notice provided directions to immediately locate and return the affected product. Receipt Confirmation was requested by calling 800-348-9500 Ext 3009 or 3983. FAX Back Response Form should be completed and returned to 574-372-1683. Questions should be direct to 574-371-3009 or 574-372-3983, M-F, 8 AM to 5 PM.

Device

Device Recall Trochanteric Nail. Long,
  • Model / Serial
    Item 28334, Lot M486130
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Nationwide (USA)
  • Product Description
    REF 28234 Troch Nail, Long 11MM, Right 34 CM || Peritrochanteric Nail System, Rx Sterile || Biomet Trauma Persippany, NJ || Rod, Fixation, Intramedullary and Accessories || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • 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