DePuy Synthes Recalls Craniomaxillofacial (CMF) Distraction Systems

Depuy Synthes has issued a recall for certain craniomaxillofacial (CMF) distraction systems, which are used to lengthen and stabilize the jaw of infants suffering from birth defects or adults following a traumatic injury. According to the manufacturer, the devices may reverse direction post-operatively, potentially leading to respiratory arrest, emergency surgery or death.

The DePuy Synthes CMF recall was announced by the FDA on Thursday, indicating that at least 15 reports of injury have been associated with the jaw lengthening systems.

An Urgent Notice was sent by DePuy Synthes in April 2014, asking hospitals and medical facilities to review their inventory and remove all of the affected CMF systems from stock. The FDA has classified this action as a Class I Medical Device Recall, suggesting that continued use of the device poses a risk of serious adverse health consequences or death.

Recalled DePuy Synthes craniomaxillofacial (CMF) distraction systems, which are also commonly referred to as an external mandibular fixator (EMF) or distractor and bone plate, are used to lengthen the mandibular body (jaw bone) and ramus (lower jaw) of patients with congenital defects or post traumatic jaw defects. The implant promotes and guides jaw bone growth, strategically attaching to either the fractured or deformed area of the jaw bone to redirect the development of the jaw over time.

Infants may be at the highest risk of serious injury if a DePuy Synthes CMF reverses direction, because a sudden obstruction of the trachea may occur, leading to respiratory arrest or death.

For older children or adults with the ability to maintain an open airway, the potential for serious consequences may be less, because failure of the DePuy Synthes CMF would not result in tracheal obstruction and would likely be medically reversible, according to the FDA. However, they may still face a need for surgical intervention to replace the failed device.

The DePuy Synthes craniomaxillofacial (CMF) implant consist of two clover leaf or mesh design plates, which are threaded with screw holes and a rigid extension arm that attaches to the two plates allowing for placement accuracy. The recalled devices came in four sizes. The first set of size’s are the 1.0mm and 1.3 mm, used for children under the age of 12 month, and sizes 1.5mm and 2.0mm are used on older patients to allow for appropriate distraction.

The CMF distraction systems are labeled as either “AB” or “BC” distractor bodies. The AB footplates are placed more anteriorly on the jaw bone with half of the distractor initially positioned posterior to the osteotomy. The BC distractor body footplates are placed more posteriorly on the mandible with the distractor body initially positioned either anterior or posterior to the osteotomy.

Patients with distractors currently implanted have been advised to contact their physicians to confirm the appropriate course of action. Recommended treatments may depend on the severity of the abnormality, the age of the patient, the patient’s caregiving environment, ability to protect their airway, and ability to maintain nutritional status to determine the best type of post-operative care and supportive treatment.