Device 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.
Z-2538-2019
Product summary
- Event
- Event 83596
- Status
- Completed
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2538-2019
Official wording
Reason: The affected products were inadvertently packaged with an incorrect screw component.
Code information: 13KSL0038C
Distribution pattern: Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Derived failure modes
-
Unknown
The affected products were inadvertently packaged with an incorrect screw component.