Medical device attorneys note the Class I recall of a DePuy Jaw Implant due to the risk of serious injury or even death posed by the device. The recalled device is known as a Craniomaxillofacial (CMF) Distraction System and is manufactured by DePuy Synthes, a subsidiary of Johnson & Johnson. Those with the highest risk of injury appear to be infants and small children, who could suffer from tracheal obstruction, respiratory arrest, and death if the CMF device fails. If you or a loved one has been injured, you may be eligible to file a DePuy jaw implant lawsuit.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated lawyer who can assist you throughout the legal process.
What is a CMF Distraction System?
According to the FDA recall notice, the DePuy CMF Distraction System
[I]s an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).
Why is There a Recall?
Intended to correct abnormalities of the jaw caused either by congenital defects or trauma, the device “may reverse direction and lose the desired distraction distance after surgery.” This reversal of direction can cause the throat to become obstructed, restricting the patient’s airway. Children or adults may be less at risk due to their ability to maintain an open airway despite the failure of the device, but infants who lack this ability could, essentially, be strangled by the obstruction of the trachea.
To date, there have been 15 reports of injury associated with the device.
DePuy sent a notice of the recall to hospitals on April 16, 2014, and the FDA announced the recall on August 28, 2014. DePuy has instructed hospitals with the recalled devices to remove them from their inventory.
According to the FDA:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The recall of the DePuy CMF Distraction System is the most serious and urgent class of recalls, as patients implanted with the device face a risk of serious injury or even death. Those who have received the DePuy jaw implant may be required to undergo surgery to remove and replace the device even if they have not yet suffered any injuries. Like those who have filed lawsuits due to Depuy hip replacements, those injured due to a DePuy CMF Distraction System may be able to file a DePuy jaw implant lawsuit in order to seek compensation for damages.
Do You Have a DePuy CMF Jaw Implant? Contact an Attorney Today
If you or a loved one have been implanted with a DePuy CMF Distraction System and suffered injury or face revision surgery of your jaw implant, contact Attorney Group today. We offer a free, no obligation consultation for patients who have been adversely affected by defective medical devices, and we can help you determine your options if you are interested in pursuing a claim against the manufacturer. We can also connect you with an experienced medical device recall attorney who can assist you in filing a DePuy jaw implant lawsuit in order to seek the compensation to which you may be entitled.