FDA-Device2015-08-05Class II
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Encore Medical, Lp
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.
Sold states
US Distribution to TX and GA.
Affected count
10 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2262-2015Don't want to check this manually?
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