The U.S. Food and Drug Administration (FDA) has put its most serious recall label on DePuy’s recall of the Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). This device 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 jaw stabilizing system are being recalled because the device might change direction and no longer stabilize with the intended distraction distance after surgery.
The recall has been categorized as Class I, meaning that exposure to the devices can lead to serious injury or death. The FDA says that the risk is highest in infants because the defect could result in the device obstructing the airway, leading to respiratory arrest and death. There is less risk for children and adults who are able to maintain an open airway if the device fails, because the trachea would not be blocked. For all patients, however, device failure may require surgery to remove the system. So far, the FDA has received 15 reports of injury associated with this defect.
The DePuy Synthes is used to stabilize the jaw and correct abnormalities in the lower jaw and the side of the lower jaw (ramus) by slowly lengthening the bone, a process known as distraction. This device is used in both children and adult patients.
An Urgent Notice was sent to DePuy Synthes customers on April 16, 2014. The notice stated that the reason for the recall was “because the device may reverse direction and lose the desired distraction distance after surgery.” In discussing the potential impact this recall could have on patients, the notice states that “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 were advised to remove the affected lots from inventory. For a return authorization number, customers can call DePuy Synthes at 1-800-479-6329.
Since 2012, Johnson & Johnson has had more Class I recalls than any other medical device company; the Synthes recall is the 12th to be dubbed as Class I.