Recall Z-1105-2018— Smith & Nephew, Inc.

Name: FDA recall Z-1105-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-01

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-02-01, terminated 2018-10-22. It names one FDA 510(k) clearance: K081111. Product: smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.. Reason: The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Terminated: 2018-10-22
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

smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

Reason for recall

The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.

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