# FDA recall Z-2538-2019

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-01-15.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2538-2019
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-01-15
- **Report date:** 2019-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2019

## Citation

> AI Analytics. FDA recall Z-2538-2019. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-2538-2019. Source: US FDA. Licensed CC0.

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