Events

Recall of Biomet Series A Asymmetrical Patella size 28mm, three pegs 184791

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
    60144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-2012
  • Event Initiated Date
    2011-10-04
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105835
  • 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
    Prothesis, knee,patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Correcting language on product labeling which incorrectly states patella buttons are intended for use with the agc knee system.
  • Action
    Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.

Device

Biomet Series A Asymmetrical Patella size 28mm, three pegs 184791
  • Model / Serial
    Part 184791, Lot 098760, 143320, 143480, 247410, 247420, 283590, 311990
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
  • Product Description
    Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. || Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
  • 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