Events

Recall of Device Recall Mallory Head Calcar Provisional

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
    55365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1666-2010
  • Event Initiated Date
    2010-03-10
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90691
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    The firm has found that some lots of mallory head revision stems had flute geometry that was out of specification. the flute geometry was too deep.
  • Action
    Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.

Device

Device Recall Mallory Head Calcar Provisional
  • Model / Serial
    Lot Number: M553140.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
  • Product Description
    Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986, Biomet Orthopaedics, Warsaw, IN. || Implant device intended for use in femoral revision surgery.
  • 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