Events

Recall of Device Recall NexGen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Trabecular Metal Technology, 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
    70605
  • Event Risk Class
    Class 2
  • Event Number
    Z-1325-2015
  • Event Initiated Date
    2015-02-04
  • Event Date Posted
    2015-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134147
  • 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/ - Product Code MBH
  • Reason
    One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
  • Action
    Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.

Device

Device Recall NexGen
  • Model / Serial
    20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in the state of CA
  • Product Description
    NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. || Product Usage: || Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • Manufacturer Address
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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