Z-2538-2019Class II

Legion(tm) Hemi Step Tibial Wedge Rk/hk, 5 Mm, Size 3-4 Lt.mdl/rt-Lat, Ref 71423432

Name: Z-2538-2019 Legion(tm) Hemi Step Tibial Wedge Rk/hk, 5 Mm, Size 3-4 Lt.mdl/rt-Lat, Ref 71423432
Creator: Smith & Nephew, Inc.
Published: 2018-01-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-01-15 / Completed / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2018-01-15. FDA classified it as Class II and gives the reason as "The affected products were inadvertently packaged with an incorrect screw component". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2538-2019
Classification: Class II
Status: Completed
Initiated: 2018-01-15
Posted: 2019-09-12
Recalling firm: Smith & Nephew, Inc.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The affected products were inadvertently packaged with an incorrect screw component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent an Urgent Medical Device Recall Notice letter dated January 15, 2018 to consignees via email. The letter identified the affected product, problem and actions to be taken. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. For questions or concerns regarding this recall contact [email protected].
Quantity in commerce: 12 units
Distribution: Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Product codes and lots: 13KSL0038C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2019	Class II	Completed	Voluntary: Firm initiated	2019-09-18	2019-09-12

Product code JWH

K043440Class IISmith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)