Stryker (NYSE:SYK) said today that the FDA sent it a warning letter stemming from an November 2012 inspection of a plant in Portage, Mich.
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.