DePuy Orthopedics Gets Hit With Class I Recall Over Lower Extremity Product

DePuy Orthopedics's voluntary recall of the LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component has been classified as a Class I recall by the FDA.

DePuy had initiated the recall July 11 because of the potential for the intercalary component to fracture when a person is walking. That can also cause pain, infection, loss of function, loss of limb, neurovascular injury and the need for repeat surgery.

The products were made and distributed from February 2007 to May 2013. Patients are being notified by surgeons and can discuss the risks of the implant fracture and the method for detecting implant failure with their patients.

Those not experiencing symptoms do not need to have any kind of revision surgery, DePuy has determined. 

UPDATE: A DePuy spokeswoman said that 96 components were sold globally between February 2007 and May 2013. The company has received seven complaints of fracture.

 -- By Arundhati Parmar, Senior Editor, MD+DI
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