Events

Recall of Device Recall DISCOVERY ELBOW

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
    68418
  • Event Risk Class
    Class 2
  • Event Number
    Z-1925-2014
  • Event Initiated Date
    2014-05-15
  • Event Date Posted
    2014-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127549
  • 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
    Surface finish is different than specified. the implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. the patient may experience pain requiring surgical intervention.
  • Action
    Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.

Device

Device Recall DISCOVERY ELBOW
  • Model / Serial
    Catalog/REF #: 114905, Lot #: M846640
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the state of California
  • Product Description
    DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. || Elbow joint replacement prostheses are 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