(Reuters) - The U.S. Food and Drug Administration on Friday said it has notified healthcare professionals of a Class I recall, the most serious type, of an orthopedic device made by Johnson & Johnson.
The device, called LPS Diaphyseal Sleeve, is used in reconstructive knee surgery. It was recalled because of the potential for fractures, the FDA said.
The agency said it has received 10 reports of incidents in which the device has malfunctioned.
The affected devices were manufactured by Depuy, J&J’s orthopedic unit, from 2008 to July 20, 2012.
A fracture in the sleeve at the joint of it could lead to loss of function or loss of limb, infection, compromised soft tissue or death, the FDA said.
The FDA said the company is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.
J&J’s Depuy is currently defending itself against a slew of lawsuits over its hip implants.
Reporting By Debra Sherman; editing by Sofina Mirza-Reid