Smith & Nephew, Inc. recalls smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The…

Recall date

September 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0092-2018

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

Why it was recalled

The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.