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.
Reported: September 18, 2019 Initiated: January 15, 2018 #Z-2538-2019
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 12 units
- Distribution
- Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 12 units.
Why was this product recalled? ▼
The affected products were inadvertently packaged with an incorrect screw component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Moderate. Recall number: Z-2538-2019.
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