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The U.K.-based medical technology company Smith & Nephew has recalled multiple components used in hip resurfacing and replacement. In addition, the company has faced several lawsuits in the U.S. alleging liability for negligence, defective design and breach of implied warranty.
R3 Constrained Acetabular Liner Recall
In August 2010, Smith & Nephew sent recall letters to distributors and hospitals informing them of problems related to the company’s R3 constrained acetabular liner and recalling all outstanding stock. The letter also advised notification of all customers to inform them of the recall. The company sent a second recall notice in September 2010. The devices recalled had been distributed in the U.S., Australia and Portugal.
R3 Metal Liner Recall
In 2007, Smith & Nephew began producing and marketing optional metal cup liners for its R3 Acetabular System total hip replacement prostheses, and the company began distributing the component globally in 2009. In 2008, the U.S. Food & Drug Administration (FDA) approved the R3 metal liner for use with the Birmingham Hip Resurfacing System, but the liners were not cleared for use with R3 Acetabular total hip replacement systems.
After reviewing Australian and U.K. patient data indicating that the R3 metal liners were not performing as well as expected, Smith & Nephew issued a voluntary global recall of the liners in June 2012. The Smith & Nephew recall represented the third worldwide recall of metal-on-metal hip replacement components by medical device companies.