The Wall Street Journal-20080116-Stryker Gets Warned Over Implants
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Stryker Gets Warned Over Implants
The Food and Drug Administration warned Stryker Corp. for failure to properly identify and correct recurring problems with some of its hip implants.
The FDA said Stryker, a medical-device company based in Kalamazoo, Mich., violated the agency's manufacturing rules at a Mahway, N.J., plant that makes hip implants and implant components. The problems were uncovered during plant inspection last June and July.
The FDA, in a warning letter posted on the agency's Web site yesterday, said Stryker received "continual" complaints from January 2005 through April 2007 involving devices that failed to function and hip implant components that had poor fixation.
The company said it would continue to work closely with the FDA to address matters raised by the letter.
