Recall Z-0092-2018— Smith & Nephew, Inc.

Name: FDA recall Z-0092-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-14

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-09-14, terminated 2020-08-21. It names one FDA 510(k) clearance: K041106. Product: smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-14
Terminated: 2020-08-21
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K041106 — REVISION KNEE SYSTEMSmith & Nephew, Inc.·cleared 2004-07-01

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 L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

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