(Thomson Reuters ONE via COMTEX) -- Kalamazoo, Michigan - March 12, 2013 - Stryker Corporation SYK -0.42% 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 www.stryker.com.
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Source: Stryker Corporation via Thomson Reuters ONE