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 17,798.49 -14.90 -0.08%
Nasdaq 5,127.53 11.39 0.22%
S&P 500 2,090.11 1.24 0.06%
Treasuries 2.22 -0.01 -0.31%
Data as of 12:14am ET
Company Price Change % Change
General Electric Co 30.36 0.00 0.00%
Bank of America Corp... 17.48 0.04 0.23%
HP Inc 12.61 -0.03 -0.24%
Pfizer Inc 32.79 -0.08 -0.24%
Walt Disney Co 115.13 -3.54 -2.98%
Data as of Nov 27


Sumner Redstone, the media mogul who controls Viacom and CBS, is at the center of a legal dispute. One side says he is practically unable to make decisions for himself. The other says he is "engaged and attentive." More

Gold futures hit a low of $1,051.60 an ounce, yet another reminder of just how out of favor gold has become since its all-time high of nearly $1,890 in 2011. More

Watsi crowdfunds donations to cover healthcare costs of those in need. And it's seeing a surprising trend: micro-donations via the popular Chinese social networking app, WeChat. More

Hive, a startup funded by the UN, is tasked with getting more Americans engaged with the refugee crisis. More

Facebook just increased the amount of paid time off new dads working at its international offices can take. More