Events

Recall of Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,

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
    53399
  • Event Risk Class
    Class 2
  • Event Number
    Z-0221-2010
  • Event Initiated Date
    2009-10-08
  • Event Date Posted
    2009-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85426
  • 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 JWH
  • Reason
    The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
  • Action
    An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.

Device

Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,
  • Model / Serial
    Lots 60932817, 60947726, 60947740, 60954160, 60958280, 60964468, 60975037, 60981811, 60987827, 60988226, 60992959, 60992960, 60992961, 61001553, 61005440, 61017701, 61027885, 61036350, 61036354, 61045085, 61051480, 61064807, 61069417, 61075244, 61078759, 61085878, 61096363, 61101462, 61106565, 61114168 and 61117040.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Product Description
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021-13. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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