Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0816-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 18, 2016

Date Posted: February 24, 2016

Recall Number: Z-0816-2016

Event ID: 73164

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

14KM16422

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated