FDA warns Stryker on quality issues, marketing practices
(Reuters) - Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility.
The letter, which followed an inspection of the facility in November, also noted that Stryker failed to notify the regulator of a product recall and had been marketing devices without required approvals.
The FDA acknowledged that Stryker has submitted corrective action plans for the quality and recall issues, Stryker said.
Stryker did not specify which Portage facility was inspected by the regulator, or which product was involved in the recall. The company did not immediately reply to an email seeking clarification on this.
However, Stryker said in its statement that the issues related to marketing practices included its Neptune surgical waste management product.
The Neptune product line and certain hip implant products were part of a series of recalls by Stryker last year.
The Neptune recall was classified as the most serious type of recall - one that involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The Neptune Waste Management System is intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities.
Over the past six months, the FDA has issued warnings to several major medical device makers including Hospira Inc, St. Jude Medical Inc and Alere Inc related to quality problems.
The FDA also imposed an import ban on a few products made by Hospira - an injectable-drugs and medical devices maker - which led to the company withdrawing its 2013 forecast.
The Kalamazoo, Michigan-based company's shares were trading flat at $66.39 on Tuesday morning on the New York Stock Exchange.
(Reporting by Esha Dey in Bangalore; Editing by Joyjeet Das, Roshni Menon)