Recall Z-0590-2015— Smith & Nephew, Inc.

Name: FDA recall Z-0590-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2014-11-04, terminated 2019-08-22. It names one FDA 510(k) clearance: K060742. Product: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.. Reason: The stem taper on this device is undersized; the gauge point is not deep enough..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Terminated: 2019-08-22
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K060742 — LEGION COBALT CHROME REVISION KNEE SYSTEMSmith & Nephew, Inc.·cleared 2006-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.