Z-0816-2016Class II

LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial...

Name: Z-0816-2016 LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial...
Creator: Smith & Nephew, Inc.
Published: 2016-01-18
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-01-18 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment on 2016-01-18. FDA classified it as Class II and gives the reason as "The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0816-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Posted: 2016-02-17
Terminated: 2016-05-25
Recalling firm: Smith & Nephew, Inc.
Product: LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.
Quantity in commerce: 8 units
Distribution: Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
Product codes and lots: 14KM16422

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0816-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0816-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-17

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)