Encore Medical, Lp recalls FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

Recall date

June 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2262-2015

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Distribution to TX and GA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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