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 Chakrabarty)