Events

Recall of Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate

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
    50546
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-2009
  • Event Initiated Date
    2008-11-25
  • Event Date Posted
    2009-01-09
  • 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=75733
  • 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 Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
  • Reason
    Sterility compromised: lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.
  • Action
    Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled "URGENT: DEVICE RECALL." Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131.

Device

Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate
  • Model / Serial
    Lot 60830979.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
  • Product Description
    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. || The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. || These are single use implantable devices sold sterile.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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