Events

Recall of Device Recall Discovery Elbow System Humeral Condyle Set Hexalobular

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
    60971
  • Event Risk Class
    Class 2
  • Event Number
    Z-1071-2012
  • Event Initiated Date
    2011-12-14
  • Event Date Posted
    2012-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106933
  • 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, elbow, constrained, cemented - Product Code JDC
  • Reason
    A discovery condyle kit w/ hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
  • Action
    December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 Monday through Friday 8 AM to 5 PM.

Device

Device Recall Discovery Elbow System Humeral Condyle Set Hexalobular
  • Model / Serial
    REF 114700, Lot 797550
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Only Distribution -- Netherlands & UK.
  • Product Description
    Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. || Intended for primary and revision joint arthroplasty for use in cemented applications.
  • 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