FDA Class I Recall for DePuy Synthes Jaw-Stabilizing Device

Johnson & Johnson’s DePuy Synthes unit initiated a recall of its jaw-stabilizing device that the Food and Drug Administration (FDA) placed in its most serious Class I recall category.

DePuy’s Craniomaxillofacial Distraction System lengthens and stabilizes bone in the lower jaw in patients with birth defects or jaw injuries, but the company uncovered a potentially deadly design flaw that could block the airway when the device is used in infants, MassDevice reports. The FDA designated this a Class I recall after DePuy reported 15 injuries associated with the device. The Class I category is reserved for situations where there is “reasonable probability” that use of a device will cause serious adverse health consequences or death.The device gradually lengthens the bone until the jaw is in the desired location, according to MassDevice. DePuy recalled the system after reports that the device may reverse direction after surgery, causing injury. In infant patients, the device may block the baby’s airway and “could lead to respiratory arrest, and result in death,” according to the recall announcement. Older children and adults face lower risk for serious injury, but device failure may still require revision surgery to replace the implant, according to MassDevice.

DePuy issued an urgent notice to health care providers in April, instructing them to remove the jaw-stabilizing system from inventory. The company recalled all lots of the device manufactured from April 20, 2009 to April 15, 201l. The implants were distributed until April 14, 2014, according to the MassDevice.

Johnson & Johnson faces problems with other medical devices.  In July the company halted sales of the power morcellator, a surgical tool used in uterine surgery that can spread undetected cancer cells in a woman’s abdomen. The FDA recently issued an advisory discouraging surgeons from using the morcellator in surgical procedures, Fierce Medical Devices reports. DePuy also faces continuing problems over its defective all-metal hip implants. Last November, the company agreed to a $2.5 billion settlement for thousands of lawsuits alleging injuries caused by the devices. The company still faces numerous lawsuits over the hip implants.

 

 

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