Our Terms of Service and Privacy Policy have changed.

By continuing to use this site, you are agreeing to the new Privacy Policy and Terms of Service.

J&J warned over illegal hip, knee device sales

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration has hit another Johnson & Johnson unit -- medical device maker DePuy Orthopaedics -- with a warning letter for selling hip and other joint products without the agency's approval.

The FDA said in the letter that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.

The agency said DePuy should immediately stop selling the Corail products or face further enforcement action, which could include product seizure, injunction or civil penalties.

The FDA said it will only evaluate whether these products can be legally marketed to consumers after DePuy submits information for approval.

Johnson & Johnson (JNJ, Fortune 500) has come under intense FDA scrutiny over the past year.

The company's McNeil Consumer Healthcare unit, which makes well-known cold and pain drugs such as Tylenol and Benadryl, has received negative inspection reports and warning letters tied to manufacturing lapses at its U.S. factories.

In May, McNeil shut a plant in Fort Washington, Penn., after the company recalled millions of children's Tylenol and other drugs that were made at that facility.

In this latest warning letter, the FDA has given Depuy 15 days to correct the violations.

DePuy Orthopaedics says it is "reviewing the letter to understand the FDA's concerns and will respond to their request for information." To top of page

Index Last Change % Change
Dow 21,394.76 -2.53 -0.01%
Nasdaq 6,265.25 28.56 0.46%
S&P 500 2,438.30 3.80 0.16%
Treasuries 2.14 -0.01 -0.42%
Data as of 8:46am ET
Company Price Change % Change
Advanced Micro Devic... 14.17 -0.21 -1.46%
Bank of America Corp... 22.82 -0.11 -0.48%
Micron Technology In... 31.73 -0.16 -0.50%
Ford Motor Co 11.04 -0.09 -0.81%
Oracle Corp 50.95 0.65 1.29%
Data as of Jun 23
Sponsors

Sections

The Senate GOP health bill would severely cut back federal support for Medicaid, which covers 1 in 5 Americans. States would have trouble filling the gap, likely leading them to cut eligibility, funding and provider rates. More

The Justice Department is fighting back against a 2016 court ruling that determined American companies don't have to hand over customer data to U.S. police if it's stored on computers in another country. More

The average guest at a wedding last year spent $888 per wedding, according to a study from the Knot. For those in the wedding party, the price of being a stand-up friend was over $1,000. More