Events

Recall of Device Recall Biomet Modular Primary Tibial Tray Implants (size 75 mm)

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
    80185
  • Event Risk Class
    Class 2
  • Event Number
    Z-2177-2018
  • Event Initiated Date
    2018-05-18
  • 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=164798
  • 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
    One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. this may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
  • Action
    On May 18, 2018, the firm notified affected distributors and user facilities of the recall through Urgent Medical Device Recall letters sent via email and FedEx. The letters informed affected consignees of the issue and stated that the affected units were distributed in March 2018. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected

Device

Device Recall Biomet Modular Primary Tibial Tray Implants (size 75 mm)
  • Model / Serial
    Lot 385340  UDI: (01) 00880304005310 (17) 280306 (10) 385340
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico
  • Product Description
    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 || Product is used 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