Medical device manufacturer Exactech has been operating since 1985 with global sales of their hip, ankle, and knee replacement devices.
A massive recall has been issued for more than 140,000 Exactech knee replacement systems implanted in the United States since 2004, as well as hundreds of Exactech ankle replacements, which contained a defectively packaged polyethylene insert that may cause implants to fail prematurely, resulting in the need for additional surgery.
The company acknowledged that it's been distributing potentially defective and dangerous medical device for two decades. The Exactech Optetrak knee replacement system was introduced in the United States in 1994. However, units sold since 2004 may have contained “out-of-specification” vacuum bags for a plastic polyethylene insert used between the knee components. This defective packaging allows oxygen to reach the plastic inserts before they are implanted, causing the component to oxidize and wear out much earlier than expected, or become damaged after it is inside in the body.
The early failure rate has caused tremendous suffering for those who've had them implanted. This is of particular concern to New Yorkers whose own Hospital for Special Surgery has had a strong relationship with Exactech and the medical device products dating back to 1994. Exactech and Hospital for Special Surgery began collaborating on knee implant development in 1992, which culminated in Exactech's licensure of Hospital for Special Surgery technologies. The resulting Optetrak comprehensive knee system has been marketed by Exactech since 1995 and represents approximately 45% of the company's sales.
New York's Hospital for Special Surgery is not the only local hospital using the Exactech devices. Both NYU Langone Orthopedic Center and the Insall Scott Kelly Institute have been implanting these devices in patients which are now the subject of medical device lawsuits in New York and Connecticut as well as 9 other states.