January 4, 2017

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

By: Judy Mathias
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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.

FDA3Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.

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