Recall of ConMed device could cost company $6M

ConMed Corp. is voluntarily recalling products in a move that could cost the company approximate $6 million.

The company’s Linvatec unit is recalling certain model numbers of battery handpieces manufactured prior to May 31, 2008, and certain lots of Universal Cable manufactured prior to Dec. 1, 2006 used with electric powered handpieces. The company issued Medical Device Safety Alert letters to customers dated July 31, 2009 providing information on findings from the company’s ongoing "continuous quality improvement process." Following discussions with the Food and Drug Administration, the company has developed a voluntary recall program for the affected products.

ConMed is a medical technology company with an emphasis on surgical devices and equipment for minimally invasive procedures and patient monitoring. Headquartered in Utica, the company’s 3,200 employees distribute its products worldwide from several manufacturing locations.

ConMed notified customers about the "unlikely possibility" for units to self-activate. Safe and effective use of the handpieces includes inserting the battery away from the operation site along with not touching or coming into contact with moving parts while inserting the battery, and to follow recommended handling and user instructions, the company noted.

In the Universal Cable letter, ConMed notified customers about the "unlikely possibility" for cables manufactured prior to Dec. 1, 2006, to cause an electric powered handpiece to self-activate. The letter instructed customers to avoid moving parts on the handpiece when the cable is inserted and to follow recommended handling and user instructions.

ConMed stated that is has received no reports of any injuries with respect to the handpieces. There were, however, two reports of "non-serious injuries" to medical personnel related to the cables, with both reports occurring in 2006 in situations in which the users did not follow instructions.

"In the unlikely event that a battery handpiece behaves erratically, users should cease using it and contact customer service at ConMed Linvatec," the company stated. "Likewise, users should not deploy cables with excessive wear or damage.