The U.S. Food and Drug Administration (FDA) issued DePuy’s Synthes device with a Class I label, its most serious warning, after the company reported 15 injuries associated with its jaw implant.
A Johnson & Johnson subsidiary, DePuy, has recently recalled its Synthes Craniomaxillofacial (CMF) Distraction System due to risks that most severely affect children and infants. The CMF devices are used to lengthen or stabilize the lower jaw to correct birth defects in infants or in traumatic jawbone events in adults by gradually lengthening the bone until the jaw is in the desired location.
The device is being recalled because it can reverse direction, causing the lengthening process to cease. Federal regulators assigned its highest risk warning to the issue after DePuy reported 15 injuries associated with the device. The agency reserves its Class I label for situations where there is “reasonable probability” that the product will cause injury or death.
The lengthening process occurs after surgery, and it if suddenly stops it can cause obstruction of the trachea or windpipe. The trachea is critically important to allow air to pass through the throat and into the lungs, so any obstruction is a medical emergency. Infants utilizing DePuy’s CMF device are most at risk of death, as sudden obstruction of the trachea could go unnoticed and lead to respiratory arrest and death.
DePuy first noticed the problem in April when it issued an urgent notice to providers to remove its jaw-stabilizing system from inventory. The company recalled all lots of the device manufactured from April 20, 2009 to April 15, 2011, but the implants were distributed up until April 14, 2014, according to the reports.
Children and adults with the CMF device who have the ability to maintain an open airway are considerably less likely to suffer a serious injury if the device fails because the trachea would not be obstructed. In all patients, however, any device failure would require immediate medical intervention.
So far, there have been 15 reports of injury associated with this specific device, and DePuy has sent an urgent notice to hospitals and consumers. This recall was initiated on April 16, 2014.
If you or a loved one suffered serious injuries or death as a result of receiving this device, you may be entitled to compensation for your damages. We are currently investigating cases related to many defective medical devices, including those manufactured by DePuy. Contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878) for a free consultation.