Events

Recall of Device Recall Comprehensive Shoulder System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    79385
  • Event Risk Class
    Class 2
  • Event Number
    Z-0980-2018
  • Event Initiated Date
    2017-12-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162190
  • 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, hemi-, humeral, metallic uncemented - Product Code HSD
  • Reason
    Zimmer biomet is conducting a medical device recall for two lots of comprehensive humeral stems. the lots were commingled during the manufacturing process and were etched with incorrect lot numbers. the size difference between the two stem sizes is 1.1 inches. it is visually recognizable by the user that the box label does not match the contents of the box.
  • Action
    On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.

Device

Device Recall Comprehensive Shoulder System
  • Model / Serial
    PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide in the states of MN, NJ, CA, TX, ND
  • Product Description
    Humeral Stem 55mm(Size 13) || Product Usage: || Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer 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