Depuy Orthopedics, Inc., a subsidiary of Johnson & Johnson sold over a dozen types of orthopedic devices without the required approval of the U.S. Food and Drug Administration (FDA). The FDA sent out a warning letter on December 8^th following an inspection from May 10, 2011 through June 7, 2011, which revealed the Depuy made 14 devices that did not receive pre-market approval from the FDA.  The unapproved devices included among other things, knee systems and hip systems.

The company responded to the Food and Drug Adminstration by claiming that they believed the devices where custom made requested by surgeons to match individual patients and that custom made medical devices have been exempt from pre-market review since 1976. In other words Depuy believed that in fact it was following the FDA’s regulations.  However the FDA maintains that they do not meet the criteria.

Steven D. Silverman, director of the office of compliance for the FDA, answered with the following regarding Depuy’s response to the allegations: “The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”  A Depuy spokeswoman said “The company has made the decision at this time not to provide custom devices”.  This issue is one of many similar problems that Johnson & Johnson and it subsidiaries has faced recently, including but not limited to faulty hip replacements also made by Depuy Orthopedics, Inc.