The London-based medical device manufacturer Smith & Nephew recalled two of their Oxinium knee replacement products. Smith and Nephew stopped sales of the products and alerted U.S. authorities of the problems associated with the knee implants in August, 2003.
Smith and Nephew announced a voluntary recall of the cementless versions of their Oxinium Genesis II and Oxinium Profix II knee replacement systems. The London-based company reported that corrective follow-up surgery was needed for about 30 of the 3,000 patients fitted with the products in the United States, according to information first published in the British publication The Guardian.
Knee implant products make up approximately $370 million of the global corporation's annual revenues of $2.2 billion (based on Feb. 8, 2003, conversion rates from U.K. pounds). The specific knee implant products recalled are believed to account for approximately $3.7 million of sales revenue.
Most recalls of defective medical devices in the United States are voluntary actions taken by the manufacturer, although the U.S. Food and Drug Administration can force a recall if the manufacturer declines to remove a defective product from the market voluntarily.