DePuy pulls a joint surgery component off the market in a move the FDA termed a Class I recall, its most serious designation.
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics is in hot water again, this time due to a limb preservation system sleeve that’s being pulled out of surgery suites in a recall rated Class 1 by the FDA.
The diaphyseal sleeve is used to reconnect tissues during joint surgery. Ten patients reported device malfunctions, leading to the finding that the sleeves can fracture when normal pressure is applied to the joint while walking. The federal watchdog agency gave the recall its most serious designation, for a device that could cause severe injury or death.