Events

Recall of Vanguard Complete Knee 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
    79250
  • Event Risk Class
    Class 2
  • Event Number
    Z-1011-2018
  • Event Initiated Date
    2017-10-03
  • 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=161749
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
  • Reason
    The affected products are labeled as a 62.5mm left femur; however, the contents are a vanguard 70mm right femur.
  • Action
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: rgarequest@zimmerbiomet.com-specify "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Device

Vanguard Complete Knee System
  • Model / Serial
    Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: FL, WI, MD, MO, and MI.
  • Product Description
    Vanguard CR Porous Femoral 62.5mm (Left Femur) || For use in total knee 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