Medical Device Safety and Recalls: DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery

A recall has been issued for the DePuy Synthes Craniomaxillofacial Distraction System.  DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery.

• Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.
• Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
• In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.

There have been 15 reports of injury associated with the use of this device. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm411589.htm

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