medical Class II Updated 2019-09-18

Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.M

Recalled Product

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.


Hazard / Issue

The affected products were inadvertently packaged with an incorrect screw component.

Issued by

FDA

Distribution: Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Lot/Code Info: 13KSL0038C
View official government recall

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