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

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

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.

Hobby Lobby Update

In the wake of the Hobby Lobby ruling with respect to the Affordable Care Act’s contraceptive coverage mandate, the Administration (which already has taken steps to fund contraception for employees affected by their employers’ exemption) is attempting also to deal with the issue by a recently-published DHHS regulation setting forth the procedures that “religious” employers might follow to gain exemption from having to provide contraceptive coverage in their sponsored health plans. The proposed rule covers both religious not-for-profits and closely held religious for-profits.