What in the world is going on with Johnson & Johnson's orthopaedic medical device division, DePuy Orthopaedics? In the midst of defending itself against an onslaught of products liability lawsuits over its metal-on-metal hip implants (DePuy ASR and DePuy Pinnacle), the company is now dealing with a Class I recall of its' LPS Diaphyseal Sleeve used in reconstructive knee surgery.
The DePuy LPS Diaphyseal Sleeve recall is due to the potential for fracturing of the device. The Food and Drug Administration (FDA) released a Safety Alert , which notified healthcare providers that Johnson & Johnson's DePuy unit has issued an urgent, Class I recall, for its LPS Diaphyseal Sleeve.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Fractures of the device that occur at the taper joint of the sleeve could cause soft tissue to become compromised and result in infection, function loss, limb loss, or death, the agency cautioned in the Alert. The FDA said the product numbers for devices, which were manufactured from 2008 to July 20, 2012, are listed in the Recall Notice.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: the FDA Safety Information and Adverse Event Reporting Program.