Aug 28 Johnson & Johnson is recalling
some lots of its implant used to correct defects of the jaw
following more than a dozen cases of injury.
The device, which is used to lengthen and stabilize the
lower jawbone and the side of the lower jaw, is being recalled
by JNJ unit DePuy Synthes as it may reverse after surgery.
The U.S. Food and Drug Administration said on Thursday the
recall was classified as the most serious Class 1 type, where
there is a probability that use of the product will cause
serious health problems or death.
Infants are at the highest risk for injury if the device,
Craniomaxillofacial Distraction System, fails because sudden
obstruction of the trachea can occur leading to respiratory
arrest and death, the agency said. (1.usa.gov/1ly1Ar3)
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb