FDA regulators have issued the highest-risk Class I label on the recall of DePuy Synthes’ Craniomaxillofacial Distraction System. The jaw implant has resulted in 15 injuries.

The recall, issued in April, includes the DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies), also called an External Mandibular Fixator And/Or Distractor and a bone plate.

The DePuy Synthes Craniomaxillofacial Distraction System is an implant used to lengthen and/or stabilize the lower jawbone and the side of the lower jaw. This device is used in pediatric and adult patients to correct congenital birth or post-traumatic defects of the jaw by gradually lengthening the bone.

DePuy Synthes recalled the device after receiving reports that certain lots may reverse direction after surgery. Infants are at the highest risk for injury 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.

In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.

Customers who have questions about this recall may contact DePuy Synthes Customer Support at 1-800- 479-6328 from 9 a.m. to 8 p.m. Monday through Friday.