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DePuy Synthes Craniomaxillofacial Distraction System Recalled (Class I): AttorneyOne Monitors and Keeps Consumers Informed
Date:9/1/2014

San Diego, CA (PRWEB) September 01, 2014

AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on DePuy Synthes Craniomaxillofacial Distraction System.

The US FDA announced on August 28, that specific lots of DePuy Synthes Craniomaxillofacial Distraction System are recalled (Class I) as the device may reverse directions after surgery. According to the FDA, the DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone and the side of the lower jaw in pediatric and adult patients to correct birth or post-traumatic defects of the jaw by gradually lengthening the bone.

The reason for the recall is that the device may reverse direction and lose the desired distraction distance after surgery. In the case of infant patients this may cause sudden obstruction of the trachea leading to respiratory arrest, and death.

So far there have been 15 reports of injury associated with the use of DePuy Synthes Craniomaxillofacial Distraction System. Among the general patient population, this failure may cause surgical intervention to replace the device.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

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