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2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “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.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

Click here for more information on the 2014 CMF Distraction System recall

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit.  For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

(Image: DePuy Synthes)