FDA-Device2019-09-18Class II
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.
Smith & Nephew, Inc.
Hazard
The affected products were inadvertently packaged with an incorrect screw component.
Sold states
Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Affected count
12 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2019Don't want to check this manually?
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