FDA considers this most serious recall status. DePuy’s recall of the Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) has been deemed Class I by the U.S. Food and Drug Administration (FDA); this is the most serious recall status, and indicates that the recalled device can cause serious injury or death. The recall was issued following reports of 15 injuries. This is Johnson & Johnson’s 12th Class I recall since 2012, which is more than any other medical device company.
The DePuy Synthes is used in adults and child patients to stabilize the jaw and correct abnormalities in the lower jaw and the side of the lower jaw (ramus). This is done through distraction, a process that slowly lengthens the bone. The Synthes is also referred to as an External Mandibular Fixator and/or Distractor and a Bone Plate.
According to an FDA Safety Alert posted on the agency’s website last Thursday, certain lots of the device are defective and can reverse direction after surgery, causing a change in distraction distance. In infants, this defect could block the airway, leading to respiratory arrest and death. Children and adults who are able to keep their airway open are at less risk because the trachea would not be blocked if the device fails. Surgery may be necessary to remove the system if it fails in all patients.
DePuy Synthes customers were sent an Urgent Notice on April 16, 2014
DePuy Synthes customers were sent an Urgent Notice on April 16, 2014. According to the notice, the recall was issued “because the device may reverse direction and lose the desired distraction distance after surgery.” In thediscussing potential impact on patients, the notice reads “There is the potential for those patients with an already compromised mandible anatomy to be at higher risk of partial or complete airway obstruction (critical obstructed airway / choking).” Customers should remove the affected lots from inventory and can call DePuy Synthes at 1-800-479-6329 for a return authorization number.