Smith & Nephew, Inc.: 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.

Recall number

Z-0816-2016

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.

Status

Terminated

Initiated

2016-01-18

Posted

not on file

Terminated

2016-05-25

Reason

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

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

8 units

Distribution

Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.

Lot, serial or model codes

14KM16422

510(k) numbers

["K043440"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1020279

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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