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FDAJune 24, 2015device

FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

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

The hazard

The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.

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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