FDA regulators put their highest-risk Class I label on the recall of DePuy Synthes’ Craniomaxillofacial Distraction System after the company reported 15 injuries associated with the jaw implant.
The devices are designed to lengthen or stabilize the lower jaw in patients with congenital or post-traumatic defects, helping to gradually lengthen bone until the jaw is in the desired location. DePuy Synthes recalled the device after receiving reports that certain lots may reverse direction after surgery.
The defect is of particular concern in infant patients because a failure in the device may block airways. "This could lead to respiratory arrest, and result in death," according to the FDA notice. Children and adults face lower risk for serious injury, but device failure may still require revision surgery to replace the implant.
DePuy Synthes, a Johnson & Johnson (NYSE:JNJ) subsidiary, issued an urgent recall notice in April this year asking healthcare providers to remove the devices from inventory and contact the company for instructions on how to return them. The device maker recalled all lots manufactured from April 20, 2009, to April 15, 2011, which were distributed up until April 14, 2014.
The company also asked doctors to keep a close eye on patients treated with the Craniomaxillofacial Distraction System.
The FDA gave the recall its Class I label, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
