PlainRecalls
FDA Devices Moderate Class II Terminated

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Reported: December 17, 2014 Initiated: November 4, 2014 #Z-0590-2015

Product Description

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Reason for Recall

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

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
45 units
Distribution
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.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.. Recalled by Smith & Nephew, Inc.. Units affected: 45 units.
Why was this product recalled?
The stem taper on this device is undersized; the gauge point is not deep enough.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0590-2015.