|By Damian Garde||Comment | Forward | Twitter | Facebook | LinkedIn|
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
Stryker Receives FDA Warning Letter
March 12, 2013
Kalamazoo, Michigan – March 12, 2013 – Stryker Corporation (NYSE: SYK) announced today that its Instruments division has received a warning letter from the U.S. Food and Drug Administration (FDA) related to observations made during a November 2012 inspection at its Portage, Michigan location.
The letter concerns quality system observations made during the inspection and cites Stryker for failing to notify the FDA of a product recall, and for marketing devices, including the Neptune Waste Management System, without a required 510(k) clearance. The letter acknowledged that Stryker Instruments has already submitted corrective action plans for the quality system and recall observations. The Company is fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit http://www.stryker.com.
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This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system and the 2.3 percent medical device excise tax; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of Trauson Holdings Company Limited; and our ability to realize anticipated cost savings as a result of workforce reductions and other restructuring activities. Additional information concerning these and other factors are contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Read more: Stryker Receives FDA Warning Letter – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/stryker-receives-fda-warning-letter#ixzz2NLtknH1A