Stryker Orthopedics Under Fire for Marketing (Lawyers and Settlements)
Portage, MI: Stryker Orthopedics has come under fire from the US Food and Drug Administration (FDA) for quality control issues and marketing concerns. Reportedly at issue is the company’s handling of its Neptune surgical waste management products, which were part of a recall in 2012. The concerns are apparently not related to the Stryker Orthopedics Rejuvenate system.
According to Businessweek(3/12/13), Stryker announced that the FDA’s warning letter came after the agency inspected one of the company’s facilities in November 2012. Stryker noted it was cited by the FDA for not telling the FDA about a product recall and for marketing certain devices without having proper approvals.
Among the device included in the warning letter was the Neptune Waste Management System, used in hospital operating rooms to remove body fluids. Certain Neptune Rover Waste Management Systems were recalled on June 8, 2012, after reports of serious injuries - including one fatality - associated with the device. Stryker also said the company has made corrective plans to address the FDA’s concerns.
Stryker did not note if its Rejuvenate hi...
