The Food and Drug Administration (FDA) has said it has received additional death and injury reports related to Stryker Corporation medical devices. Stryker’s Neptune waste management system was designed to remove fluids from patients, but reportedly has caused serious injury or death to patients in surgery.
The FDA alleges that the Neptune and Neptune 2 were not submitted for device approval and that Stryker failed to inform the FDA of a device recall it issued for the Neptune. The company also manufactures the recently recalled Stryker Rejuvenate and Stryker ABGII hip replacement systems.
Stryker issued a Rejuvenate and ABG II recall in July 2012 after discovering the metal-on-metal hip device could cause serious injuries. Patients have complained of metallosis, pain, swelling and other severe hip replacement complications that required revision surgery.