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Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained
Recalled September 18, 2019 · FDA recall Z-2538-2019 · Smith & Nephew
Hazard
The affected products were inadvertently packaged with an incorrect screw component. · FDA Class II
Units
12 units
Sold at
Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Description
The affected products were inadvertently packaged with an incorrect screw component.
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →