Events

Recall of Device Recall Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabilized, Gender Sol

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
    53860
  • Event Risk Class
    Class 2
  • Event Number
    Z-0501-2010
  • Event Initiated Date
    2009-11-13
  • Event Date Posted
    2009-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86693
  • 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 implant - Product Code JWH
  • Reason
    The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
  • Action
    Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.

Device

Device Recall Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee Posterior Stabi...
  • Model / Serial
    Lot 61042477.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Korea and Switzerland.
  • Product Description
    Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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