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FDAJanuary 15, 2018device

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 collate...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Completed

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 collate... — Recall Details · AllClear