FDA Device recall Z-2538-2019
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 designe…
- FDA Device
- Class II
- completed
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of 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 designe… by Smith And Nephew, citing the affected products were inadvertently packaged with an incorrect screw component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2538-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-01-15 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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.
Reason
The affected products were inadvertently packaged with an incorrect screw component.
Identifiers
| code_info | 13KSL0038C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2538-2019%22
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