Smith & Nephew Hip Implant Recalls
This London based medical device manufacturer issued a recall of its Genesis II and Profix II Knee Implants to the Food and Drug Administration in 2003. The recall was a result of the failure of the knee implant systems to bond properly to the bone when implanted. This caused increased pain and loosened joints in patients with the knee implant systems. The failure of these knee implant products led a number of patients to have additional surgeries to fix the problem. These additional surgeries resulted in longer rehabilitation times for the patient and also heightened risks during the operation.
In 2007, Smith & Nephew issued another recall after a subcontractor incorrectly packaged the medical manufacturer’s BIRMINGHAM Hip Resurfacing System implants. As a result of the subcontractor error, different sizes of acetabular cups were packaged together.
Smith & Nephew began another voluntary recall in January of 2008 of its TC-PLUS, VKS, and RT-PLUS product lines. The medical implant manufacturer was informed by one of its suppliers that the semi-finished knee implant castings contained higher-than-specified iron content. The products being recalled were manufactured by Smith & Nephew’s subsidiary, Plus Orthopedics.