FDA warns J&J's DePuy for selling unapproved device components

January 18, 2012 by MassDevice staff

The FDA issues a warning letter to Johnson & Johnson subsidiary DePuy for allegedly selling more than a dozen device components not properly cleared by the watchdog agency.

DePuy logo

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics finds itself in the FDA spotlight, according to a warning letter released by the agency's Centers for Devices & Radiological Health this week.

The watchdog agency detailed more than a dozen devices or device components it said lacked proper PMA clearance or which were modified in ways that merit a new 510(k) application.

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