Medindia On Mobile
Custom Search

Register
Sign In
Sign In Using Facebook
HOME NEWS HEALTH A-Z HEALTH CENTRES HEALTH TOOLS DIRECTORIES SERVICES WEBSITES BUY ONLINE BLOGS COMMUNITY DOWNLOADS
Home » Corporate News

FDA Asks Johnson & Johnson To Stop Marketing Hip System

by Gopalan T on  August 27, 2010 at 11:29 AM Corporate News
  •   Print
  •   Share
  •   Comments
  •  Text 
FDA Asks Johnson & Johnson To Stop Marketing Hip System
The US Food and Drug Administration (FDA) has asked pharma giant Johnson & Johnson's DePuy Orthopaedics Inc to stop selling its Coral Hip System for unapproved uses and to provide information needed for the agency to approve the TruMatch software.


The FDA's warning letter, addressed to DePuy President David Floyd, was posted on the agency's website on Tuesday. The letter is dated Aug. 19. It is signed by Timothy A. Ulatowski, director of the Office of Compliance in the FDA center that oversees medical devices.

The FDA states that the Corail Hip System is approved for total hip replacement in patients with six specific types of damage to the hip. But a brochure on DePuy website claims the system can be used for treating two other conditions.

"Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice," the agency said in the letter. "These actions include, but are not limited to seizure, injunction, and or civil money penalties."

As for the TruMatch System, it uses software and high-tech CT scanning technology to create a detailed, 3-D view of a patient's knee so a surgeon can properly position a knee implant.

"A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law," the FDA said in the letter.

Page 1 Page 1 | 2  Next
 Email Email   RSS Feeds RSS Feeds   Print this page Print   Save this page Save   Link Link   Syndicate Syndicate   Comments Comments   Bookmark and Share
 
More News on: Fracture Neck of Femur, Waist to Hip Ratio
Comment & Contribute
Be the first to comment!
Comments should be on the topic and should not be abusive. Comments are normally moderated and are reviewed after they are posted.
* Your comment can be maximum of 2500 characters

Notify me when reply is posted
I agree to the terms and conditions 		  

X

Medwonders Health Network

Total Members - 54904
Support Groups - 445
Login  Join Now
Medwonders Health Network
  • Health News Index
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
News Archive
Date :
Category :
Keyword :
  • News Quick Links
News Central Health Watch
Latest Health News Health In Focus
News Category (500+) Breaking Health News
Popular News Celebrating Life
Health News and Press Release Medindia - Exclusive
News Photo Gallery India Special
News Video Gallery Lifestyle and Wellness
News From Other Resources
News Categories:  
Sexual Health Center

Corporate Related News
» Pfizer Initiates Recall of Birth Control Pills in the US » J&J Initiates Voluntary Recall of Aveeno Baby Lotion
» Fortis to Launch Chain of Dialysis Centers to Broaden Access to Quality Care » Pacific Edge Buoyed by European Acceptance of Gastric Cancer Detection Patents
» FDA Approves Abbott’s Xience Prime Coronary Stent » Circadian Technologies’ Investigative Cancer Drug Receives FDA Nod for Clinical Trials
» CooperVision Issues Another Statement Over Contact Lens Recall » Conditional Nod for Proposed Teva Buy
Read More >>
Follow us on : YouTube on Medindia.net Facebook on Medindia.net Twitter on Medindia.net Googleplus on Medindia.net Tumblr on Medindia.net RSS Iphone Digg on Medindia.net Stumbleupon on Medindia.net Delicious on Medindia.net

Consumers

Online Consults Child Health Teen Health Men's Health Women's Health Senior Health Sexual Health Mental Health Dental Health Kidney Health
Diabetes Obesity Vision Care Diet & Nutrition Know Your Body Amazing Body Facts Health Facts Conditions by Specialties Disease FAQs Medical Humour

Medical Professionals

Clinical Tools Health Videos Animation Slides Medical Aphorism Medical Conferences Jobs Journals Web Journals Open Access E-articles
Distance education Doctors Homepage Hospitals Homepage Personalize Info Matrimonial Print Oath Alumni Medical Humour Buy Books

Medical Students

Admissions Medical Colleges Medical Electives Medical Aphorism Post Grad Courses Indian Universities USMLE Centers CGFNS Centers
FRCS in UK PLAB USMLE CGFNS Alumni MCQ Bank Medical Humour Buy Books

Directories

Doctors Hospitals International Hospitals Chemists Surgical Suppliers NGOs Pharmaceuticals Medical Colleges
Home About us Career Sitemap Press Portfolio Advertise Contact Us
Disclaimer - The contents of this site are for informational purposes only. Always seek the advice of a qualified physician for any doubts.
Advertise with us Medindia Copyright Privacy Policy Terms of Use © All Rights Reserved 1997 - 2012