J&J's Orthopedic Device Recall over Bone Fracture Concerns: FDA
The U.S. Food and Drug Administration announced recall of an orthopedic device manufactured by Johnson & Johnson. The recall has been classified as 'Class I recall' which is the most serious type of recall issued by the agency.
The device is used to restore function in people suffering from knee injuries, reports Reuters.
FDA said that it received 10 reports of fractures and other injuries that are related to the use of the LPS Diaphyseal Sleeve made by Johnson & Johnson. The affected devices were manufactured between 2008 to July 20, 2012, in J&J's orthopedic unit DePuy Synthes.
The agency said that the device wasn't working as intended and the risk of using the device includes loss of limb, infection or death of tissue.
De Puy, in January, 2013, had issued a voluntary recall of the products.
"DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms," FDA said in a statement about the recall.
J&J said it is being investigated by the U.S. Justice Department over its marketing strategies for certain hip replacement products recalled in 2010 due to safety concerns, reports Reuters Health.