Healthcare Industry News:  bone void filler 

Devices Orthopaedic Neurosurgery Litigation

 News Release - June 17, 2009

Synthes Statement Regarding Indictment by U.S. Government

West Chester (PA), USA, June 16, 2009 - (HSMN NewsFeed) - Synthes (SWX: SYST.VX) learned today that the U.S. Attorney for the Eastern District of Pennsylvania has charged the company in connection with alleged off-label promotion of "Norian XR", a Spine product the company stopped selling in 2004. Off-label promotion involves marketing a product in a manner not approved by the FDA.

Synthes has fully cooperated with the government's investigation, which began in 2006, and believes that its marketing practices in connection with "Norian XR" were proper. The company intends to vigorously defend itself against the charges.

"Norian XR" is a calcium phosphate based bone void filler that was cleared for sale by the U.S. FDA (Food and Drug Administration) in 2002 as a medical device to treat bone voids or defects in the skeletal system. Synthes marketed "Norian XR" from 2002 to 2004, having sold approximately 200 units, realizing total net sales of approximately US$ 400,000 only.

As a global leader in the medical device industry, Synthes has a long reputation for setting the highest legal and ethical standards in the development and commercialization of medical products focused on improvement in patient care. Synthes maintains a comprehensive legal and ethical compliance program, which is regularly reviewed and updated.

Synthes: A leading medical device company Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.

For further information please contact
Gilgian Eisner, Investor Relations, Synthes, Inc.
Phone +41 32 720 47 45
Email: investor.relations@synthes.com
http://www.synthes.com
Image Bank

A selection of product and company images can be found on http://www.synthes.com/html/Media-Corner.7325.0.html?&L=0.

Restrictions Subject to US Securities Law

Synthes, Inc. management believes certain statements in this media release may constitute "Forward-Looking Statements" within the meaning of the "Private Securities Litigation Reform Act of 1995". These statements include but are not limited to those with respect to the potential for Synthes to offer new products and market existing ones, as well as the expected sales and sales growth of Synthes. These statements are made on the basis of management's views and assumptions regarding future events and business performance as of the time the statements are made. Actual results may differ materially from those expressed or implied. Such differences may result from the ability of Synthes to successfully develop and introduce new products and services and market existing products and services in a competitive marketplace and changes in the economic conditions that may affect the performance of the operations of Synthes. In addition, changes in competitive conditions and regulatory developments may affect future business performance, and changing market conditions may affect the valuation of Synthes securities. In addition, it should be noted that past financial and operational performance of the company is not necessarily indicative of future financial and operational performance. Synthes undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The securities of Synthes have been offered and sold outside the United States and have not been and will not be registered under the U.S. Securities Act of 1933, as amended ("Securities Act"). Such securities may not be offered, sold or transferred in the U.S. or to U.S. Persons (as defined in the regulations of the Securities Act), except pursuant to a registration statement filed under the Securities Act or under an applicable exemption under the Securities Act. Hedging transactions involving such securities may not be conducted unless in compliance with the Securities Act. The Synthes securities are deemed "Restricted Securities" as that term is defined in Rule 144 under the Securities Act.


Source: Synthes

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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