Want to know what's happening next in healthcare?

MedCityNews is the leading online news source for the business of innovation in healthcare.

“Follow MedCity News if you want to know who is doing what in healthcare innovation - and whether it's working or not.”

Chris Seper, CEO & Founder, MedCityNews.com

Sign up for our daily newsletter

FDA warns Stryker on quality issues, marketing practices

March 12, 2013 9:06 am by | 0 Comments

(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 also said Stryker failed to notify the regulator of a product recall, and had been marketing devices without approval.

The FDA acknowledged that Stryker has submitted corrective action plans for the quality and recall issues, Stryker said.

Stryker shares were down about 0.5 percent at $65.90 in premarket trading.

(Reporting by Esha Dey in Bangalore; Editing by Joyjeet Das)

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.