Recall Z-2538-2019— Smith & Nephew, Inc.

Name: FDA recall Z-2538-2019
Creator: U.S. Food and Drug Administration
Published: 2018-01-15

Class II · Completed

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-01-15. It names one FDA 510(k) clearance: K043440. 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: The affected products were inadvertently packaged with an incorrect screw component..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Completed
Initiated: 2018-01-15
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K043440 — SMITH & NEPHEW, INC. REVISION KNEE SYSTEMSmith & Nephew, Inc.·cleared 2005-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.