A DePuy medical device recall has been issued for the manufacturer’s Craniomaxillofacial (CMF) Distraction System, a device designed to treat congenital birth defects in infants and traumatic jaw injuries in older children and adults. The recall was issued by the U.S. Food and Drug Administration (FDA) in August 2014, following at least 15 reports of injuries associated with the device.
If you would like to learn more about your legal options if you believe you have been injured by the device, contact Attorney Group for Louisiana today. There is no cost or obligation to speak with us, and we can help to answer the questions you may have. If we find that you have a case, we can put you in contact with an affiliated Louisiana DePuy CMF jaw implant lawyer who can help you throughout the legal process.
DePuy Medical Device Recall Issued
DePuy issued a recall in April 2014 and the FDA placed a Class I label on the recall in August 2014, Class I meaning that the device had the potential to cause serious injury or death. DePuy reportedly issued an urgent safety notice to its customers and medical facilities in which the company urged them to locate and immediately remove all of the lots of the company’s products that were affected by the recall. However, individuals who have already received the device may require surgery if the device prematurely fails.
According to the FDA recall notice, specific lots may potentially reverse direction and become unable to meet the desired distraction distance. The CMF jaw implant has small plates that adhere to the jawbone, gradually distracting (lengthening), the side of the lower jaw or the lower jawbone over time. However, in the event that the device reverses, the distractor’s screws turn in the opposite direction, subsequently loosening the device instead of tightening it as intended.
Adults and older children are not typically at risk for severe or life-threatening complications. Routine screening can identify reversal, in which case serious injury can be avoided. The first recall notification issued by DePuy does, however, caution that those with an already weak or compromised jaw anatomy are at an increased risk of complete or partial airway obstruction or choking.
Infants and small babies who receive a device that prematurely fails are most likely to experience severe or life-threatening injuries. According to the FDA notification, should the device fail, sudden tracheal obstruction can occur. The infant could then suffer from respiratory distress and/or death. If you lost a child due to a complication caused by a CMF jaw implant or you or a loved one has been injured, please consider seeking legal counsel from a Louisiana DePuy CMF jaw implant lawyer to learn more about your legal options.
A Louisiana DePuy CMF Jaw Implant Lawyer Can Help
Contact Attorney Group for Louisiana today for more information if you or someone you love was fitted with the implant and you believe you have a case for compensation. In a free, no obligation consultation, we can help determine whether you are eligible to recover damages for your injuries. If you are, Attorney Group for Louisiana can also connect you with an affiliated DePuy CMF Jaw implant lawyer in Louisiana. He or she can file a lawsuit on your behalf and help you seek the compensation to which you may be entitled. Call today.