|Titanium elastic nail inserter--Courtesy of DePuy|
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.
The company is now in the process of developing a replacement and recovery plan for the involved devices. But it doesn't have enough inventory currently to remove and replace the device entirely.
DePuy Synthes has instead proposed that it remove and replace the device "in increments to prevent any adverse impact on the availability of the device for use on patients in trauma-related surgery events," the FDA said in a statement.
This is just the latest recall in a long list of quality-control issues for the consumer and medical conglomerate. Most recently, it had a recall for an electrophysiology cardiac catheter from Biosense Webster. It's also facing ongoing litigation around devices including the power morcellator that has been used in minimally invasive hysterectomy surgery in a procedure that could spread existing cancer in the body as well as faulty hip implants.
- here is the FDA recall notice