The U.S. Food and Drug Administration (FDA) announced a recall of Greatbatch Medical’s Standard Offset Cup Impactor, a surgical tool used in hip joint replacement surgery. This recall was initiated on July 29, 2016, after the device failed testing for sterility after being sterilized in a dedicated instrument case. This recall has been identified by FDA as a Class I recall, the most serious recall status. FDA states in its recall notice that use of these medical devices may cause serious injury or death.
What Is a Standard Offset Cup Impactor?
In hip joint replacement surgery, the hip socket is removed and replaced with a prosthetic cup, and the head or ball of the femur (thigh bone) is removed and replaced with a prosthetic ball.
Standard Offset Cup Impactors are handheld, reusable devices surgeons use to implant the cup in the hip sockets during this procedure. They must be thoroughly sterilized before surgery to ensure patient safety.





