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FDAJune 19, 2020device

EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

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

The hazard

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

What to do

FDA enforcement status: Ongoing

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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