Events

Recall of Device Recall Avenir Muller Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer GmbH.

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
    79677
  • Event Risk Class
    Class 2
  • Event Number
    Z-1525-2018
  • Event Initiated Date
    2018-02-28
  • 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=162957
  • 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, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    A potential commingle that could result in the product in the package not matching the product on the outer label.
  • Action
    On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following: 1.Review this notification for awareness of the contents. 2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants. 3.Your Zimmer Biomet sales representative will remove the affected implants from your facility. 4.Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to fieldaction.emea@zimmerbiomet.com. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.

Device

Device Recall Avenir Muller Stem
  • Model / Serial
    Lot Number: 2905496
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
  • Product Description
    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
  • Manufacturer
    Zimmer GmbH

Manufacturer

Zimmer GmbH
  • Manufacturer Address
    Zimmer GmbH, Sulzerallee 8, Winterthur Switzerland
  • 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