The recall of the Smith and Nephew knee replacement systems, Oxinium Genesis II and Oxinium Profix, was a "voluntary recall." This does not necessarily mean the U.S. Food and Drug Administration (FDA) would not have forced a recall if the manufacturer had not acted first.

According the FDA "Medical Device Recalls" information:

"Recalls may be conducted on a firm's own initiative or by FDA request. If the company does not comply with FDA's recall request, the FDA can seek a court order to seize the product, require the manufacturer to cease distribution and/or require the manufacturer to notify all persons who use the product.

"Most recalls are carried out voluntarily by the manufacturer or distributor of the product. However, FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the firm does not recall the product on their own. The cooperation between FDA and its regulated industries has proven to be the quickest and most reliable method to remove potentially dangerous products from the market."