FDA hits DePuy with Class 1 recall over joint sleeve

February 24, 2013 by Sony Salzman

DePuy pulls a joint surgery component off the market in a move the FDA termed a Class I recall, its most serious designation.

DePuy Orthopaedics logo

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.

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DePuy has stopped selling the device and is advising surgeons to return any unused devices they still have on hand. DePuy stopped manufacturing the diaphyseal sleeve in July 2012 and sent out a recall notice to affected customers Jan. 4. The FDA announced the recall last week.

DePuy parent Johnson & Johnson is contending with a spate of recalls spanning its divisions in recent years, including its consumer pharmaceutical business and the DePuy ASR hip implant recall, which is shaping up to be the largest-ever recall of any product. Recent reports indicate that another of DePuy's metal-on-metal hip implants is set for a recall; DePuy also settled a knee implant case in Australia last December, agreeing to shell out up to $68,200 per patient.