By Stacy Lawrence
Johnson & Johnson’s ($JNJ) DePuy Synthes issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.
These inserter devices typically are used in surgeries to fix fractures in the long bones–either in the lower extremities of pediatric and small-statured patients or in the upper extremities for other adult patients. It can also be used in small long bone fractures in areas such as the carpal and tarsal bones.
In early February, DePuy Synthes said it sent a recall notice to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it.