Alleged violations including mishandling of complaints, inadequate responses to patient injury reports, insufficient environmental controls and others. The FDA said, for example, that ConMed didn’t properly respond to 18 complaints associated with the Altrus Tissue Fusion System over "burns, potential burns, or hand-pieces that were ‘too hot’."
The inspectors concluded that the Altrus system is adulterated and misbranded under FDA law, saying the company doesn’t have proper premarket approval for the device. ConMed has 15 days from the arrival of the letter to respond to the FDA’s concerns.
The FDA noted that ConMed had initiated a recall for 2 lots of the Altrus hand-pieces, but said that the company had failed to "address and evaluate the risk of external burns to patients" even after the devices were associated with 8 complaints of external burns since the December 2010 and July 2011 release of its 5mm and 10mm Altrus hand-pieces.
Other FDA concerns included excessive air particulate levels during equipment manufacturing without subsequent evaluation, incomplete, insufficient evaluation and documentation of a design change to the Altrus hand-pieces and software and incorrect information recorded on complaint records, according to the memo.
ConMed in October answered the agency’s concerns, but the FDA deemed the responses inadequate in many cases.
The FDA letter, dated January 29, was published online on February 6. CNMD shares closed last night at $48.40, down 0.3% on the day. Share are up nearly 14% since the start of the year.