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Encore Medical, Lp recalls FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Recalled August 5, 2015 · FDA recall Z-2262-2015 · Encore Medical
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. · FDA Class II
Units
10 units
Sold at
US Distribution to TX and GA.
Description
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.
Product
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →