A medical device that is supposed to help correct birth defects involving the lower jaw is now haunting its West Chester manufacturer, Johnson & Johnson’s DePuy Synthes, with a life-threatening defect of its own that is capable of blocking infants’ airways.

The Food and Drug Administration recently classified the recall of the device, called the Craniomaxillofacial Distraction System, as one of the nation’s most serious health threats, according to an alert in Fierce Medical Devices.

DePuy has acknowledged 15 injuries linked to devices made from 2009 to 2011 and distributed until April 14 of this year. The company is also still settling lawsuits over defective all-metal hip implants that have amounted to $2.5 billion and counting.

Read more about the recall as well as other troubles and opportunities at DePuy Synthes and its parent company, Johnson & Johnson, in Fierce Medical Devices here.