The FDA announced a class I recall (class I is its highest designation) of the DePuy Synthes Craniomaxillofacial Distraction System. DePuy Synthes has issued a recall of specific lots because the implant may reverse direction and cause complications. The FDA only issues a Class I notice for situations where there is “reasonable probability” that the product will cause injury or death. Infants are at the highest risk of injury.
The device is used to lengthen and stabilize bone in the lower jaw for patients with birth defects or post-tramatic defects.
- Sudden obstruction of the trachea in infants. This could lead to respiratory arrest and death.
- Failure in adults and children with the ability to maintain an open airway are less at risk as failure should not cause a tracheal obstruction.
- Surgical intervention and replacing of failed device.
The FDA has received 15 reports of injury from use of this system.
If you or a loved one has questions regarding complications from using the Depuy Synthes Craniomaxillofacial Distraction System, please call the experienced attorneys at the Ruth Law Team (888) 783-8378