Events

Recall of Device Recall NexGen Complete Knee Solution

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
    65413
  • Event Risk Class
    Class 2
  • Event Number
    Z-2004-2013
  • Event Initiated Date
    2013-06-07
  • Event Date Posted
    2013-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118823
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Action
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.

Device

Device Recall NexGen Complete Knee Solution
  • Model / Serial
    all codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Japan.
  • Product Description
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; || 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; || 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; || 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; || 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; || 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; || Used in total knee arthroplasty and indicated for patients with severe pain.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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