Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK Recalled by Smith & Nephew, Inc. Due to The affected products were inadvertently packaged with an...

Date: January 15, 2018
Company: Smith & Nephew, Inc.
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.

Affected Products

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.

Quantity: 12 units

Why Was This Recalled?

The affected products were inadvertently packaged with an incorrect screw component.

Where Was This Sold?

Foreign countries of; France, Germany, Netherlands, Norway, Switzerland

About Smith & Nephew, Inc.

Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report