An Arthrex tibial tray recall was issued in March 2016, after the company discovered a problem with the knee implant.
According to the Arthrex tibial tray recall, the outer part of the knee implant had a smooth texture that made it incompatible with other components with a rough texture.
This incompatibility ultimately spurred the company to issue the Arthrex tibial tray recall.
The Arthrex tibial tray is a component of the Arthrex iBalance Total Knee Arthroplasty (TKA) system, which was designed to restore knee joints that were seriously damaged by disease or injury.
Arthrex specifically designed the iBalance TKA knee implant to help treat multi compartmentalized knee cartilage deterioration caused by degenerative arthritis or traumatic arthrosis.
Arthrex marketed the iBalance TKA as an alternative to total knee replacement implants, with the company designing the product to reduce the need for revision surgery.
Typical knee replacement surgery involves using plastic or metal caps placed on the end of the bones, to form the knee joint and kneecap. Comparatively, the iBalance TKA was meant to prevent further cartilage damage and reduces the need for revision surgery that is often required for the prosthetics.
The iBalance TKA was approved through the FDA’s 510(k) process,…