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 …read more.