Integra Recalls Collagen Products After Manufacturing Woes

Law360, New York (April 11, 2013, 4:44 PM EDT) -- Medical device maker Integra LifeSciences Holdings Corp. on Wednesday announced it was recalling two lots of its DuraGen meningeal grafts and other collagen products manufactured at its Puerto Rican production plant, citing deviations from approved manufacturing processes.

According to the announcement, an internal quality assurance review at Integra’s Anasco, Puerto Rico, facility had resulted in the company discovering that some of its collagen products had higher levels of endotoxins — toxins produced by bacteria — than acceptable under its product specifications.

The affected products include its...
To view the full article, register now.