March 12 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,
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
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
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