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/HK
    • 5 MM
    • SIZE 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

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