LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
The affected products were inadvertently packaged with an incorrect screw component.
Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2019