FDA Determines Knee Device Should Not Have Been Cleared for Marketing

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Determines Knee Device Should Not Have Been Cleared for Marketing

FDA Determines Knee Device Should Not Have Been Cleared for Marketing
Thu, 14 Oct 2010 12:08:00 -0500

The U.S. Food and Drug Administration today announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States. The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency’s review of the device.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? support@xxxxxxxxxxxxxxx
• Other inquiries? webmail@xxxxxxxxxx

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420