Z-2538-2019 Class II
FDA device recall Z-2538-2019 was initiated by Smith & Nephew, Inc. on Jan 15, 2018 and is designated Class II. Reason for recall: The affected products were inadvertently packaged with an incorrect screw component. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2019
- Initiation Date
- Jan 15, 2018
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2538-2019
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026