Recall Z-2090-2016— Smith & Nephew, Inc.

Name: FDA recall Z-2090-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-26

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-05-26, terminated 2019-08-16. It names one FDA 510(k) clearance: K081111. Product: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.. Reason: The surface inside of the femoral component, where cement is applied for adhesion, is below specification..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Terminated: 2019-08-16
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K081111 — LEGION HINGE KNEE SYSTEMSmith & Nephew, Inc.·cleared 2008-07-23

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) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Reason for recall

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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