FDAFDA · Food and drugs·Recall number 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 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.
Published September 18, 2019 · Recall initiated: January 15, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The affected products were inadvertently packaged with an incorrect screw component.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
- Lot
- 13KSL0038C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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