FDA Warns DePuy About Distributing "Custom" Devices Without Approvals

WASHINGTON, D.C. - The U.S. Food and Drug Administration has warned DuPuy Orthopaedics that an inspection of its Warsaw, Ind., facility turned up "customized" hip, ankle, knee and other replacement devices that are being distributed without proper approvals or clearances.

The FDA warning letter was sent to DePuy on Dec. 8 after inspectors discovered that DePuy was misbranding devices made to fulfill requests from individual surgeons as "customized."

The FDA said, the procedures being used by DePuy and its products engineering staff in fulfilling such requests does not conform to Section 520(b) of the Food, Drug and Cosmetic Act …