Events

Recall of Device Recall NexGen LPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ZIMMER ORTHOPEDIC MFG LTD.

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
    78960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-2018
  • Event Initiated Date
    2017-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160970
  • 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, metal/polymer, mobile bearing - Product Code NJL
  • Reason
    There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
  • Action
    On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131

Device

Device Recall NexGen LPS
  • Model / Serial
    Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
  • Product Description
    NexGen LPS Femoral Component, Left and Right, Size G || Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
  • Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD

Manufacturer

ZIMMER ORTHOPEDIC MFG LTD
  • Manufacturer Address
    ZIMMER ORTHOPEDIC MFG LTD, Building No 2 East Park, Shannon Industrial Estate, Shannon Ireland
  • 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