Parker Waichman LLP is reviewing claims concerning serious injuries and deaths involving the DePuy Synthes Craniomaxillofacial (CMF) Distraction System Jaw-Stabilizing device.
DePuy Synthes is a unit of healthcare giant Johnson & Johnson. The DePuy Synthes CMF Distraction System (AB Distractor Bodies and BC Distractor Bodies) is also known as an External Mandibular Fixator and/or Distractor and a Bone Plate. The device is an implant that lengthens and/or stabilizes the mandibular body (the lower jawbone) and the ramus (the side of the lower jaw). The device is used to correct congenital (birth) defects or defects caused by trauma.
To date, there have been two Class I recall designations and numerous reports of pediatric injuries associated with the DePuy Synthes device. Parker Waichman LLP continues to monitor the recall activities related to the DePuy Synthes CMF Distraction System.
Numerous Injury Reports associated with DePuy Synthes’ CMF Distraction System
DePuy Synthes discovered that the CMF Distraction System has a potentially fatal design flaw in which airways may become blocked in infant patients. According to the FDA, at least 15 injuries have been associated with the Craniomaxillofacial Distraction System, which may reverse direction and lose the desired distraction distance following surgery. Infants are at the greatest risk for injury should the system fail as a sudden tracheal obstruction may occur. When this occurs, respiratory arrest and death may take place.
In all patient populations, device failure may lead to the need for surgical intervention to replace the failed device.
DePuy Synthes CMF Distraction System the Subject of Two FDA Class I Recall Designations
U.S. Food and Drug Administration (FDA) Class I recall designations are, according to the agency, “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
On August 28, 2014 federal regulators deemed a recall issued by DePuy Synthes of its CMF Distraction System Jaw-Stabilizing device a Class I.
On April 16, 2014, DePuy Synthes issued an urgent notice to providers about the issue with its CMF Distraction System Jaw-Stabilizing device, advising providers to remove the system from inventory. The FDA deemed that notification a Class I recall. According to the FDA announcement, DePuy Synthes indicated that the CMF Distraction System (AB Distractor Bodies and BC Distractor Bodies) may reverse direction and lose what is known as the “desired distraction distance” following surgery.
Although DePuy Synthes recalled all lots of the jaw-stabilizing system from April 20, 2009, to April 15, 2011, the implants continued to be distributed until April 14, 2014.
The recall was the 12th recall issued by Johnson & Johnson since 2012 that was deemed a Class I by federal regulators. At the time of the recall, Johnson & Johnson had the greatest number of recalls involving medical devices that were deemed Class I recalls by the federal regulators.
Legal Help for Victims of the DePuy Synthes CMF Distraction System
If you or a loved one sustained injury following use of the DePuy Synthes CMF Distraction System, you may have valuable legal rights, including filing a DePuy Synthes CMF Distraction System lawsuit. We urge you to contact our medical device injury lawyers today by filling out our online form, or calling the firm, toll-free, at 1-800-YOURLAWYER (1-800-968-7529).