Events

Recall of Device Recall Vanguard 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
    80172
  • Event Risk Class
    Class 2
  • Event Number
    Z-2183-2018
  • Event Initiated Date
    2018-05-11
  • Event Date Posted
    2018-06-01
  • 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=164769
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The label master file was errantly set up as a 63/37mm instead of a 63/67mm. there is no 63/37 size offered, and the product is laser marked with the correct size.
  • Action
    The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall (Removal)" letters dated 5/11/2018 to customers on 5/11/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 1. Review this notification and ensure affected team members 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. a. Return a digital copy to corporatequality.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. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returning product box(es) clearly with RECALL. 5. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts in accordance with local regulations. 6. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voice mail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Device Recall Vanguard Knee System
  • Model / Serial
    UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150;  UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480;  UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730;  UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370;  UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750;  UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970;  UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680;  UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370;  UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470;  UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060;  UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330;  UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220;  UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080;  UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
  • Product Description
    Vanguard Knee System PS Tibial Bearing, Part Number 183621 || Intended for use in knee joint replacement procedures.
  • 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