Encore Medical, LP recalls EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Recalled Product
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Hazard / Issue
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.
Issued by
FDA
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