FDA Warns Stryker on Quality Systems, Recalls, and Neptune Marketing
Stryker says the FDA sent it a warning letter over problems with its quality system at a plant in Michigan, failing to notify the federal watchdog agency about recalls and for the marketing of its Neptune waste management device.
The Kalamazoo, Mich.-based medical device company said the letter, based on "quality system observations," flagged it for failing to tell the federal watchdog agency of a product recall and for marketing devices including its Neptune waste management system without 510(k) clearance from the FDA.
"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," according to a press release.