Federal Drug Administration Recalls “External Mandibular Fixator And/Or Distractor”

The Federal Drug Administration recently recalled a device used in reconstructive facial surgery commonly termed a “External Mandibular Fixator And/Or Distractor with Bone Plate.”

This device is being recalled because some of these devices have lost “distraction tension” (the ability to stabilize and/or pull bones and tissue apart) which allows the facial bones / neck tissue / and or plates to collapse and this can result in the blockage of the airway and the suffocation and death of the patient.  

This defective surgical device presents a disproportionate threat to children and adolescents who represent the age groups which most commonly undergo surgery to correct facial birth defects.

If you have any questions or need further information do not hesitate to contact me.

Illinois Attorney George M. Sachs
Telephone: 847-362-2800