Events

Recall of NexGen

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
    37069
  • Event Risk Class
    Class 2
  • Event Number
    Z-0650-2007
  • Event Initiated Date
    2006-10-10
  • Event Date Posted
    2007-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49850
  • 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
    knee prosthesis surgical instrument - Product Code JWH
  • Reason
    The device was cut to an incorrect angle, which may result in an incorrect bone cut.
  • Action
    Product was removed from customer location during visit on 10/10/2006.

Device

NexGen
  • Model / Serial
    Lot 97000417.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    One medical facility in Michigan.
  • Product Description
    NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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