Johnson & Johnson was recently slapped with a Class I recall of 157,000 surgical staples used to treat hemorrhoids. Malfunctions of these surgical devices can lead to extremely adverse health issues, including severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal, dehiscence of the rectal wall staple line and even death.
The device was recalled due to problems in the firing mechanism used to install the staples, which may result in incomplete firing stroke that may result in an incomplete staple formation. The recall includes those lots manufactured between April 16, 2011 and July 24, 2012. The devices are used in the surgical treatment of prolapse and hemorrhoids (PPH).
Under FDA guidelines, Class I recalls are mandated when there is a reasonable probability that use of these products will cause serious adverse health consequences or death. If you or a loved one suffered complications as the result of these defective surgical staples, contact the product defect attorneys at Powers Taylor LLP for a free case evaluation.