DePuy Synthes is recalling the Craniomaxillofacial (CMF) Distraction System, a jaw stabilizing system, because it can reverse direction and obstruct the trachea, cause respiratory arrest, or death. The defect has been linked to 15 injures.
Overview
The Craniomaxillofacial (CMF) Distraction System helps gradually lengthen and stabilize bones in the lower jawbone (mandibular body) until the jaw is in an appropriate location.
It is designed to lengthen or stabilize the lower jaw in infants who are born with birth defects. It is also used in children and adults who had congenital abnormalities or traumatic injury to the jaw.
Other names for this device include:
- External Mandibular Fixator
- Distractor
- Bone plate
What is the problem?
August 28, 2014 — The FDA has issued a Class I recall because the devices can reverse direction and lose the desired distraction distance after surgery.
According to the FDA:
“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 who can keep their airway open have less risk of injury because device failure will not obstruct the trachea. In all patients, failure of the device may result in the need for surgery to replace the device.
Class I Recall
DePuy Synthes, a Johnson & Johnson subsidiary, issued an urgent recall on April 16, 2014. They asked customers to remove affected products from inventory and contact the company for instructions on how to return them. The recalled products were sold between November 3, 2009 and April 14, 2014.
For a complete list of affected products with part and lot numbers, review the recall notice.
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