Events

Recall of Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPSFLEX Femoral Component

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
    52003
  • Event Risk Class
    Class 2
  • Event Number
    Z-1522-2009
  • Event Initiated Date
    2009-04-17
  • Event Date Posted
    2009-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81876
  • 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 - Product Code NJL
  • Reason
    The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
  • Action
    Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.

Device

Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPSFLEX Femoral Component
  • Model / Serial
    Lots 61204820, 61215983, 61219677,61219684 and 61227758.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.
  • Product Description
    Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left , sterile, Zimmer, Warsaw, IN; REF 00-5964-017-51.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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