Events

Recall of Zimmer Gender Solutions

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
    75371
  • Event Risk Class
    Class 2
  • Event Number
    Z-0317-2017
  • 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=150155
  • 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
    Saw, powered, and accessories - Product Code HAB
  • Reason
    Complaints have been reported that the handpiece is inoperable. the investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. an inoperable device may lead to a delay in surgery.
  • Action
    On 9/28/2016,  URGENT MEDICAL DEVICE FIELD REMOVAL notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Managers and Surgeons Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with quarantining all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility for the initial preventative maintenance and arrange for a loaner device. It is estimated that your handpieces will undergo preventative maintenance sometime between November 2016 and March 2017. 4. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to CPWARFieldAction@zimmerbiomet.com or via fax to 574-372-1683 within three (3) days. b. Retain a copy of the Acknowledgement Form with your field removal records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field removal that are recommended beyond your existing follow up schedule. 3. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to

Device

Zimmer Gender Solutions
  • Model / Serial
    Item Number 00-5927-040-00 Serial Number All
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
  • Product Description
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis || Milling Handpiece
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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