Legal news for New York Product Liability Lawyers – FDA and Conmed recall surgical instruments due to potential risk.
Utica, NY (NewYorkInjuryNews.com) – The Food and Drug Administration (FDA) www.fda.gov/default.htm in cooperation with Conmed Linvatec Corp. has now voluntarily recalled the following surgical instruments due to accounts of battery powered tools self-activating, working after having been turned off, and the tools moving in the wrong direction when in use.
This recall is to create awareness to discontinue use of the specified surgical tools for medical professional’s namely orthopedic surgeons, hospital risk supervisors and surgical service administrators. This is a class 1 recall of two models identified as PRO5 and PRO6 and a Universal Cable product number MC5057.
The handpieces PRO5 and PRO6 have been widely used from the release date in March 29 through June 24, 2009. Those distributed after May 2008 are not affected by this safety recall. The cables were sold and used from January 24, 2001 to February 27, 2009. Those cables manufactured after December 1, 2006, are not a part of this voluntary recall.
Conmed Corporation has required that all medical professionals utilizing these surgical tools to stop use immediately if the handpiece activates itself or the tool works when it has been shut off. Medical professionals may return the cable or the handpiece to Conmed for assessment and service to the units.
In 2006, 2 medical personnel experienced minor injuries when using the tools; however they had not followed directions for use. No other injuries have been reported as of yet. In the event where someone experiences an injury or other adverse reaction with the tools, it should be reported to the FDA’s Med Watch Adverse Event Reporting Program on the FDA’s website.
Bridget Hom
NewYorkInjuryNews.com