Events

Recall of Device Recall Biomet BioloxDelta Modular Ceramic Head

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
    52092
  • Event Risk Class
    Class 2
  • Event Number
    Z-1613-2009
  • Event Initiated Date
    2009-03-16
  • Event Date Posted
    2009-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82081
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    The firm has received reports of fractured heads, requiring revision surgery.
  • Action
    Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached "Fax-Back Response Form" to Biomet at 1-574-372-1683. Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.

Device

Device Recall Biomet BioloxDelta Modular Ceramic Head
  • Model / Serial
    Lots 114380, 175490, 229000, 310710, 342670, 385840, 403940, 467870, 484970, 572770, 641430, 705380, 761420 and 792280.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales.
  • Product Description
    Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112. || A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.
  • 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