Smith & Nephew, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0589-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Product Classification:

Class II

Date Initiated: November 4, 2014

Date Posted: December 17, 2014

Recall Number: Z-0589-2015

Event ID: 69759

Reason for Recall:

The stem taper on this device is undersized; the gauge point is not deep enough.

Status: Terminated

Product Quantity: 24 units

Code Information:

Lot Number 14FM05730

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

Voluntary or Mandated:

Voluntary: Firm initiated