FDA Warns Stryker Again Over Quality Control

Law360, New York (May 5, 2008, 12:00 AM EDT) -- Stryker Corp. has come under fire from the U.S. Food and Drug Administration again, three months after it pulled a number of its popular Trident hip replacement components off the market following an FDA warning.

On Friday, the Kalamazoo, Mich.-based medical technology company revealed that its Biotech unit had received a warning letter from the FDA. The letter concerned Stryker's quality systems and compliance issues at its Hopkinton, Mass., facility. No recalls were connected with the letter, Stryker said.

The letter, which cited observations made by...
To view the full article, register now.