ANOTHER RECALL FOR DEPUY/JOHNSON & JOHNSON
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Healthcare professionals were issued yet again, in early January, an Urgent Medical Device Recall-also known as a Class I recall- for the LPS Diaphyseal Sleeve from the FDA and DePuy Orthopaedics (Johnson & Johnson.) The LPS Diaphyseal Sleeve, a device intended for reconstructive knee surgery, could cause patients fracture and DePuy advised surgeons to immediately cease any distribution of the device.
10 reports of device malfunction were given to the U.S. Food and Drug Administrators who took action to prevent any future infection, loss of limb, and even death from a fracture of the sleeve at the taper joint. Manufactured from 2008 to July 20, 2012, the insufficiency in potentially accommodating physiological loads of patients were too great of a concern for the FDA to ignore.
DePuy Orthopadeics, a medical device division of Johnson & Johnson, are also under fire for its metal on metal hip implants. DePuy is recommending surgeons to discuss with patients the risks of the device and strategies to distinguish restorative failure