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.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds, “We are determined to keep an eye on FDA announcements concerning DePuy Synthes Craniomaxillofacial Distraction System and inform the public. For that reason," he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
The announcement states that “on April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers. The notice identified the problem, affected products and tells customers to review their inventory and remove affected lots from stock,” among others.
AttorneyOne.com has further information on DePuy Synthes Craniomaxillofacial Distraction System at the website, including the latest major drug, food, and medical products law news.
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