FDAnews Device Daily Bulletin

OSSUR ANNOUNCES RECALL OF TOTAL KNEE

April 4, 2006
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Iceland-based prosthetic maker Ossur has announced a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee prosthetic device. The company's initiation of the recall is based on a finding that some units may contain faulty pins in the axis of the knee.

There have been no incidents or injuries resulting from this situation. To date, the incidence of actual product failures within the recalled knees is less than one percent.

The serial numbers of the affected knees were ordered from June 7, 2005 to present and Ossur has temporarily suspended sales and shipments of Total Knees until further notice. The implementation of a replacement program is effective immediately.

"We take the issue of patient safety very seriously," said Jon Sigurdsson, president and chief executive officer of Ossur. "We instituted this recall immediately, upon learning of the faulty pins, because we believe that the patient's well-being is our first priority. In addition, we are taking measures to guarantee the quality and safety of the replacement knees."

Ossur will continue to provide regular and frequent updates as more information becomes available. For more information, access the company website at www.ossur.com (http://www.ossur.com).