Smith & Nephew, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2538-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 15, 2018

Date Posted: September 18, 2019

Recall Number: Z-2538-2019

Event ID: 83596

Reason for Recall:

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

Status: Completed

Product Quantity: 12 units

Code Information:

13KSL0038C

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated