The Food and Drug Administration recently alerted doctors that Johnson & Johnson's orthopedic device is subject to recall over a Class I recall, the most serious type. The device, the LPS Diaphyseal Sleeve, is used in knee reconstruction surgery and is linked to fractures.
The FDA has received 10 reports of knee fractures from individuals with the device in their bodies. A fracture in the sleeve could lead to loss of function of the knee or even loss of the entire limb. Other possible consequences include infection, compromised soft tissue or death.
The affected devices were manufactured between 2008 and July 20, 2012. Johnson & Johnson is not recommending revision or additional follow-up for individuals with the sleeve in place who haven't experienced any adverse effects. This is the first case of faulty or dangerous devices for J & J; the company is also in the process of defending itself against a slew of lawsuits over its DePuy hip implants.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.