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FDAnews Device Daily Bulletin

Smith & Nephew Recalls Implants

Dec. 6, 2007

Smith & Nephew has begun a precautionary recall of knee implants from its TC-PLUS, VKS and RT-PLUS knee ranges.

The company said it was informed by a UK supplier that a limited number of semi-finished knee implant castings have a higher than specified iron content. These castings were manufactured during May and June on behalf of the company’s subsidiary Plus Orthopedics.

The higher iron content in these knee products is a result of a production error at the supplier’s factory, the company said, adding that the products have been supplied mainly to customers in Europe, with some to the U.S. and other countries. All affected products are being recalled as a precautionary measure.