DePuy Orthopaedics Component Gets Class I Recall

FDA has given Class I status to a recall related to the DePuy Orthopedics Limb Preservation System (LPS). In particular, the Lower Extremity Dovetail Intercalary component of the device was recalled last month owing to the potential fracture of the intercalary component during normal walking. FDA explains that the defect can lead to "additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery." In particular, patients who weigh more than 200 pounds or who are especially active face the highest risk of the implant component breaking. According to MD+DI, 96 components were sold internationally and the company has received seven reports of fracture.