DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall
Class I recalls of medical devices or drugs are the most serious type of recall. They are issued when there exists “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the U. S. Food and Drug Administration.
The FDA notified healthcare professionals on 8/28/2014 of a Class I DePuy recall of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). This device is also called an External Mandibular Fixator and/or Distractor and a Bone Plate. The device is used to lengthen and/or stabilize the lower jawbone (mandubular) and the side of the lower jaw (ramus). It is used to correct congenital or trauma-induced jaw defects in both children and adults by gradually lengthening and stabilizing the jawbone. The DePuy CMF Distraction System creates and gradually widens a gap in the jawbone, which gap is filled in over time by bone growth.
The recall affects 200 lots of the DePuy CMF Distraction System. The reason for the recall is that the affected lots were found to be prone to reversing direction after surgery – preventing the jaw from correcting and stabilizing. According to the FDA Safety Alert,
* 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.
* In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.
See the Urgent Recall Notice for a complete listing of the affected products, including parts and lot numbers. The Urgent Notice sent by DePuy Synthes tells its customers to removed affected inventory from their stock.
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