Events

Recall of NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor

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
    55363
  • Event Risk Class
    Class 2
  • Event Number
    Z-0610-2011
  • Event Initiated Date
    2010-04-16
  • Event Date Posted
    2010-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90685
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The impactor may disassemble or detach during use. the detached piece may not be observed intraoperatively and may be left in the surgical site. complications may include pain, infection, and prolongation in surgery. these complications may also require revision surgery.
  • Action
    Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.

Device

NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor
  • Model / Serial
    77706800, 79006000, 50088600, 51580800, 52153800, 60009328, 60040337, 60050566, 60067099, 60139584, 60195841, 60236368, 60266687, 60297665, 60537409, 60633099, 60777631, 60856861 and 60931933.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
  • Product Description
    NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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