Reported Sep 18, 2019 · Completed
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK5 MMSIZE 3-4 LT.MDL/RT-LAT
- REF 71423432 Product UsageThe 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
- Lot codes and dates
- 13KSL0038C
- Amount recalled
- 12 units
Why it was recalled
The affected products were inadvertently packaged with an incorrect screw component.
This product could cause temporary or reversible health problems — stop using it.
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