Events

Recall of Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor

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
    70297
  • Event Risk Class
    Class 2
  • Event Number
    Z-1208-2015
  • Event Initiated Date
    2015-01-07
  • Event Date Posted
    2015-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132897
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
  • Action
    Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor
  • Model / Serial
    Part Number: 010000589 Lot: 527400
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: AL, FL, NY, TX Foreign: None
  • Product Description
    Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, || Part Number: 010000589 || Lot: 527400
  • 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