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FDASeptember 19, 2016device

Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.

What to do

FDA enforcement status: Terminated

Brands named

encore medical lpencoreencore medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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