UPDATE 1-US FDA tells J&J unit to halt hip device sales

* Agency: Corail Hip System not approved for certain uses

* FDA says TruMatch knee device also needs approval

* Agency sends J&J’s DePuy warning letter on Aug. 19

* DePuy disputes some of FDA’s claims, reviewing letter

* J&J shares down 1.5 percent

By Susan Heavey

WASHINGTON, Aug 24 (BestGrowthStock) – The U.S. Food and Drug
Administration is ordering Johnson & Johnson’s (JNJ.N: ) DePuy
Orthopaedics unit to halt sales of its Corail Hip System for
unapproved indications after marketing such “off-label” use,
according to a warning letter made public on Tuesday.

DePuy’s TruMatch Personalized Solutions System for
artificial knees also lacks FDA approval, the agency said. The
FDA asked the company to submit information so it can decide
whether the product can be legally marketed.

But in a statement, DePuy said it did not believe that
TruMatch needs “FDA clearance or approval because it is an
instrument system.” It also said that the issue with its Corail
hips related to “specific wording” in company promotions.

“We are reviewing the letter to understand the FDA’s
concerns and will respond to their request for information,”
the company said.

FDA’s letter comes amid a tighter crackdown on medical
devices, including possible changes to the approval process
under Margaret Hamburg, whom the Obama administration appointed
to head the FDA.

DePuy’s Corail hip product is FDA-approved for total hip
arthroplasty to help improve patients’ mobility, the agency
said, but it is only supposed to be used without cement. A
brochure on the company’s website promoted cement use, which is
not approved.

Such changes “represent a major change or modification in
the intended use of your device that require a new premarket
notification,” the FDA wrote in the letter, dated Aug. 19. It
asked the company to submit a list of all promotional materials
for the hip system that include claims for unapproved uses as
well as explain its plan for halting them.

For the TruMatch product, FDA said its records showed the
company did not seek approval before selling the artificial
knee positioning system and called on the company to submit an
application. The system uses a computerized scan of a patient’s
leg to help surgeons place and position an artificial knee.

“The FDA will evaluate the information you submit and
decide whether your product may be legally marketed,” it said.

DePuy Inc, which manufactures various products for joints,
the spine and neurological surgery, is one of dozens of units
making medical devices for its diversified healthcare parent
Johnson & Johnson, along with Ethicon Inc, Cordis Corp and
other subsidiaries.

The FDA released the letter on its website at

Shares of J&J were down 1.5 percent at $58.01 in midday
trading, slightly lower than the over all S&P 500 Index (.SPX: ),
which was down 1 percent.
(Reporting by Susan Heavey; Editing by Lisa Von Ahn and
Matthew Lewis)

UPDATE 1-US FDA tells J&J unit to halt hip device sales