FDA: Class I recall of Standard Offset Cup Impactor by Greatbatch Medical

Editor's Note

The Food and Drug Administration (FDA) on December 20 classified the recall by Greatbatch Medical (Frisco, Texas) of its Standard Offset Cup Impactor with a POM-C handle as Class I, the most serious.

The recall was issued because the Impactor failed sterility testing when sterilized in a dedicated instrument case. Greatbatch has developed new sterilization recommendations; the device must be individually wrapped during sterilization processing.

The Impactors are reusable handheld devices used during hip joint replacement surgical procedures to implant cups in the hip socket.

Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.