Z-2538-2019 Class II
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- January 15, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
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.
Reason for Recall
The affected products were inadvertently packaged with an incorrect screw component.
Distribution Pattern
Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Code Information
13KSL0038C