|The FDA issued Stryker a warning letter for improperly marketing devices, including Neptune.--Courtesy of the FDA|
The FDA hit Stryker ($SYK) with a warning letter for failing to disclose a recall and selling devices without agency clearance.
Stryker revealed that the agency took issue with its quality systems and chided it for marketing the Neptune waste management system, among other devices, without attaining 501(k) clearance. The company didn't disclose which recall irked the FDA or what other devices it sold without the agency's OK, and a Stryker spokeswoman didn't respond to a request for comment Tuesday.
The problems arose during a November inspection of Stryker's Portage, MI, facility, the company said, and the FDA acknowledged that Stryker has already submitted corrective action plans to get clear of the warning. Stryker says it's working with the agency to resolve the matter as soon as possible.
Just what the corrective process entails remains unknown. The FDA is generally sluggish to post warning letters on its website, and Stryker isn't getting into any further detail. The company recalled Neptune last year, and the FDA applied its most-serious Class I designation to the move, but it's unclear whether more recalls are coming as the agency cracks down on Stryker's unapproved marketing of other devices.
- here's the release