The U.S. Food and Drug Administration (FDA) has labeled DePuy’s recall of the DePuy Craniomaxillofacial (CMF) Distraction System as a Class I recall, denoting that the device has the potential to cause serious injury or death. The device, manufactured and marketed by DePuy Synthes, a subsidiary of Johnson & Johnson, has the potential to prematurely fail. If it does, the device can cause serious and life-threatening complications such as respiratory distress, particularly in infants.
If you believe you have been adversely affected by the DePuy CMF Distraction System, consider working with a DePuy jaw implant lawyer to learn more about your legal options. Attorney Group for Oklahoma is providing free, no obligation consultations to individuals who believe they have a case. If it is determined that you are eligible, we can then put you in touch with an affiliated DePuy jaw implant lawyer who can file your lawsuit on your behalf.
CMF Distraction System Overview
The jaw implant is intended to correct abnormalities of the jaw in both children and adults. The process of distraction, or gradual lengthening, is used in adults who suffered from a traumatic jaw injury and in infants who were born with congenital birth defects. The device features screws that attach the device to the patient’s jawbone and stretch out the bone over time.
Problems with the CMF Distraction System
However, 15 reports of complications have been submitted to the FDA on behalf of patients who allegedly experienced problems due to the device. According to the FDA, the screws that connect the device to the jawbone can begin to reverse direction, loosening the device instead of tightening it. If this happens in adults, a reversal can typically be caught and treated with an additional surgical procedure. Adults and older children are generally able to control their airways and are not likely to suffer from a severe or life-threatening tracheal obstruction.
Infants, on the other hand, are at an increased risk of respiratory distress and death should the device prematurely fail because they lack the ability to “breathe around” the obstruction. As a result of these alleged problems, DePuy issued an urgent notice in April 2014 informing its customers and the medical community of the possible complications. Hospitals were urged to pull the affected lots from their inventory and to contact DePuy for additional information.
Individuals who believe they have been adversely affected by the device are urged to consult with a DePuy jaw implant lawyer in Oklahoma to determine whether they are entitled to seek compensation for their injuries. Possible damages may include medical expenses, loss of earning capacity, pain and suffering, lost wages, and more.
Contact a DePuy Jaw Implant Lawyer in Oklahoma
If you believe you are entitled to recover damages for injuries that you feel were caused by the DePuy CMF Distraction System, Attorney Group for Oklahoma can help. There is no cost to speak with us, and we can put you in contact with an affiliated DePuy jaw implant lawyer in Oklahoma if we find that you are entitled to seek compensation for your injuries. Call today.