Stryker Gets FDA Warning Letter After Inspection
Orthopedic maker Stryker Corp. said Tuesday that it received a warning from government regulators about quality control issues and unapproved marketing of medical devices.
The company said it got the letter from the Food and Drug Administration following a November inspection of its Portage, Mich., facility.
Stryker did not release the letter, but said the FDA cited the company for not notifying regulators about a product recall. The FDA also cited the company for marketing medical devices, including the Neptune Waste Management system, without a government-approved application. The Neptune device is a suction system used in the operating room to dispose of body fluids.
Stryker noted that it has already submitted plans to the FDA for correcting the problems cited in the warning letter.
The FDA regularly issues warning letters to companies that don't follow regulations for manufacturing and marketing drugs, medical devices and other products. The letters are not legally binding, but the FDA can take companies to court if they are ignored.
Stryker shares rose 42 cents to $66.64 in afternoon trading.