Certain implants used in adults, children and infants to lengthen and stabilize the lower jawbone or side jaw to correct birth defects or post-traumatic defects are being recalled because the device may reverse direction. To date, this device defect has caused 15 injuries in patients. The recall involves the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). It is also referred to as an External Mandibular Fixator, External Mandibular Distractor and a Bone Plate. Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur, leading to ... Read More
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