Events

Recall of Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, 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
    68457
  • Event Risk Class
    Class 2
  • Event Number
    Z-1936-2014
  • Event Initiated Date
    2014-05-19
  • Event Date Posted
    2014-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127986
  • 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
    Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
  • Action
    Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.

Device

Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • Model / Serial
    Size 5, includes the following Lot numbers: 370318 37214652 61424997 61442318 61442319 61442320 61451223 61454955 61454956 61459968 61459969 61459970 61475130 61475131 61475132 61488234 61518182 61518183 61518184 61526402 61543977 61567344 61567345 61592091 61592092 61627258 61627260 61643935 61643936 61658884 61658885 61658886 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 62377651 62423843 62455679 62460240 62460242 62460243 62525441 62525442 62586581 62586582 62610910 62610911 62610912 62640982 62646149 62646150
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • Product Description
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, 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